MCLA-145-CL01: A Phase 1, Open-label, Dose-escalation study of MCLA-145 in participants with advanced or metastatic malignancies 

• Preferred: NSCLC, melanoma, H&N, urothelial cancer or MSI-H/dMMR tumors with PD-L1 >=1%, that already received previous anti-PD-L1 (no slots)

• Dual CD137 + Anti-PD-L1 antibody 
• Prior anti-PD-1 is allowed (max 1 line)
• Mandatory pre- and on-treatment biopsy
• Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma

 NCT03922204

MATTERS: A mono-centric, first in-human (FIH), safety and preliminary efficacy study of (neo)adjuvant, model-based, whole-body hyperthermia (WBHT) treatment in advanced solid cancer patients or stage IV (TxNxM1) metastatic pancreatic adenocarcinoma patients

• Cohort A2: The highest whole-body hyperthermia duration with acceptable side effects from cohort A1 will be applied to three additional patients with advanced solid cancer, once a week and for 15 days in total
• Cohort C: Three pancreatic cancer patients will be treated with 3 times 4 hours hyperthermia using the device (Q2W) and in combination with chemotherapy (GEMOX)

EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies.

All tumortypes with:

• Moderate hepatic impairment -> slots
• Severe hepatic impairment -> slots 

• Moderate hepatic impairment: bilirubin from 1.5 to 3 x ULN
• Severe hepatic impairment: bilirubin >= 3 x ULN
• Oral tazemetostat
• Intensive PK sampling

NCT04241835

TRIDENT-1: A Phase 1/2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

• Solid tumors with NTRK rearrangements

• Solid: maximum 2 prior TKI’s, no limit on prior lines of chemotherapy/immune therapy

• Oral repotrectinib = novel TKI
• Different cohorts according to prior TKI and chemo/immune therapy

NCT03093116

TAPISTRY/BO41932: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

• Cohort A: solid tumors with ROS1 fusion, except NSCLC
• Cohort B: solid tumors with NTRK1/2/3 fusion
• Cohort C: solid tumors with ALK fusion, except NSCLC

• Cohort A: prior SOC/none available, prior ROS1 inhibitor is exclusion
• Cohort B: prior SOC/none available, prior NTRK inhibitor is exclusion
• Cohort C: prior SOC/none available, prior ALK inhibitor is exclusion

• Cohort A: entrectinib oral
• Cohort B: entrectinib oral
• Cohort C: alectinib oral

NCT04589845

MCLA-129: Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors

• Part 1 - Cohort 6: HNSCC, ESCC, GC/GEJ with EGFR amplification or c-MET amplification, NSCLC with EGFR mutations including TKI sensitizing mutation (e.g. 19del and L858R) and/or approved TKI-resistance mutations (e.g. T790M, C797S, L792, L798I, exon 20 insertion), or any activating c-MET mutation/amplification, or c-MET exon 14 exon skipping mutation (no slots)
• Part 2 - Cohort B: NSCLC cMet exon 14 skipping mutation (screening paused)

• Cohort 6: prior SOC (>1L) or ineligible/intolerant
• Cohort B: ≥ 2L, capmatinib and tepotinib resistant or ≥ 2L, TKI naïve

• MCLA-129 IV Q2W: biospecific monovalent EGFR x cMET antibody
• Mandatory on-treatment biopsy
• Intensive PK sampling with overnight hospital stay
• Cohort B, 6: MCLA-129 monotherapy

NCT04868877

GO42144: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

• CRC
• NSCLC
• All other 

• Oral study medication
• Intensive PK sampling 

NCT04449874

BT5528-100: A Phase I/II study of BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

• Urothelial cancer (no slots)
• Ovarian cancer (no slots)
• NSCLC (no slots)
• H&N (no slots)
• TNBC (no slots)
• Gastric/upper GI (no slots)

• Prior SOC 
• No limit to number of prior treatment regimens

• Prescreening for EphA2 expression is no longer needed
• BT5528 IV QW or Q2W
• Intensive PK sampling during first cycle

NCT04180371

AMG 20190135: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

• Subprotocol F, all cohorts: NSCLC
• Subprotocol H: 
• Cohort F: CRC

• Subprotocol F: 
• Cohort A1: 1st line (no prior platinum, no prior anti-PD(L)-1)
• Cohort A2: prior anti-PD(L)-1 mono or prior platinum-based combination (waiting list)
• Sobprotocol H:
• Cohort F: no prior therapy

• Subprotocol F:
• Cohort A1 and A2: sotorasib + carboplatinum + pemetrexed
• Subprotocol H:
• • Cohort F: sotorasib + panitumumab + FOLFIRI
• Mandatory screening and on-treatment biopsy 

CL1-95012-001: A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

• Prior SOC, no restriction on number
• Prior anti-PD(L)-1 is allowed

• PRS-344/S095012 IV Q2W
• Intensive PK sampling during cycle 1 and 2

20210023 (AMG193): AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) 

• NSCLC
• Cholangiocarcinoma (BTC)
• HNSCC
• Pancreatic ductal adenocarcinoma (PDAC)

• NSCLC: 1-3 prior lines, including anti-PD(L)-1, platinum-based chemo and targeted therapy (if applicable)
• BTC: 1-2 prior lines, including platinum-based chemo and targeted therapy (if applicable)
• HNSCC: 1-2 prior lines, including platinum-based chemo and anti-PD(L)-1
• PDAC: 1-2 prior lines, including standard chemo

• AMG193 monotherapy
• AMG193: PRMT5 inhibitor, oral, QD

20210104 (AMG 552): A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301) 

• Head and neck squamous cell carcinoma (cohort closed)
• Lung adenocarcinoma (cohort closed)
• Triple-negative breast cancer (cohort closed)
• Intrahepatic cholangiocarcinoma (cohort closed)
• Ovarian epithelial cancer (cohort closed)
• Endometrial cancer (cohort closed)
• Cervical cancer (cohort closed)
• Other FGFR2b+ solid tumors (cohort closed)

• TNBC: at least 2 lines
• Lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor and targeted therapy if a targetable mutation is present
• All other tumor types: at least 1 line

• Bemarituzumab (AMG 552): a monoclonal antibody against FGFR2b, IV Q2W
• Pre-screening for central IHC FGFR2b overexpression (tissue <10y)

WP43295: A phase 1a/b open-label study to evaluate safety, pharmacokinetics, and preliminary clinical activity of RO7276389 alone and in combination with cobimetinib in participants with BRAF-V600 mutation-positive advanced solid tumor or BRAF-V600 mutation-positive melanoma with central nervous system metastases

• Part 1: Metastatic or locally advanced solid tumors with BRAF-V600 mutation
• Part 2: Cutaneous melanoma with asymptomatic brain metastases (not yet open)

• RO7276389: a potent RAF inhibitor targeting mutant BRAF V600E/K protein
• Part 1a, part 2 cohorts 1 & 2: monotherapy RO7276389
• Part 1b, part 2 cohorts 3 & 4: combination RO7276389 with cobimetinib

61186372GIC2002 (ORIGAMI-1): A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

• Cohort D, E: 2L

• Amivantamab: an antibody directed against EGF and MET receptors
• Cohort D: amivantamab + mFOLFOX6
• Cohort E: amivantamab + FOLFIRI
• Mandatory screening biopsy

20200469: A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer

• Part 1, 2, 3: AMG757 (tarlatamab) + carboplatin/etoposide + atezolizumab
• Part 5: AMG757 (tarlatamab) + atezolizumab 

MK6482-016: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

• Cohort A: HCC (closed)
• Cohort E: endometrium (closed)
• Cohort F: ESCC (open)

• Cohort A: 1L
• Cohort E: 1L, non-MSI-H
• Cohort F: 2L, IO naïve

• Pembrolizumab Q6W + lenvatinib + belzutifan
• Belzutifan: inhibitor of HIF-2α
• Lenvatinib: inhibitor of VEGFR1-3

KBA1412-101: A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with advanced solid malignant tumors 

• Part A: all solid tumors
• Part B, C: melanoma, ovarian cancer, gastric cancer, CRC

• Part A: All
• Part B, C: Prior PD(-L)1 therapy, if this is SOC

• Part A, B: KBA1412 monotherapy
• Part C: KBA1412 + pembrolizumab
• KBA1412: anti-CD9 human monoclonal antibody, IV

DAY101-102: A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

• DAY101 monotherapy
• DAY101: oral type II pan-RAF kinase inhibitor
• Archival tissue <1y old

DO2.22.01: A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours

• Treatment naive with no current options
• Prior SOC (prior MET inhibitor without PD is allowed)
• Intolerance

• DO-2: Oral MET kinase inhibitor

1403-0011 (Brightline-2): A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced/metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

• Cohort 1: prior SOC or ineligible
• Cohort 2-4: prior SOC

• BI 907828 monotherapy
• BI 907828: oral MDM2-p53 antagonist, Q3W, 45 mg 
• MDM2 amplification and TP53 wild type on local testing

INCA 32459-101: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

<= 2L

• INCA32459 monotherapy
• INCA32459: LAG-3 x PD-1 bispecific antibody, IV, Q3W
• Part 2: mandatory fresh biopsy at screening and on treatment

1456-0001: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors

• BI 1831169 monotherapy
• BI 1831169: virus immunotherapy
• Arm A: Intratumoral administration
• Arm B: Intravenous administration (not yet open)
• Arm C: IT + IV (not yet open)
• Very limited slots

GO43860: A Phase IA/IB, open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, and activity of RO7502175 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors

Selected solid tumors with PD-L1 >=1% (>=10% for esophageal)

Phase 1A: monotherapy

• Cohort A: NSCLC, HNSCC, cutaneous melanoma (on hold)
• Cohort B: triple negative breast cancer (TNBC), urothelial cancer, esophageal, gastric, gastro-esophageal junction, cervical, clear cell renal cell carcinoma, HCC (not yet open)

• Phase 1B: CPI-experienced NSCLC (no slots)
• Phase 1B: CPI-experienced HNSCC

• Phase 1A: RO7502175 monotherapy
• Phase 1B: RO7502175 + atezolizumab
• RO7502175: Anti-CCR8 monoclonal antibody, IV, Q3W 
• Mandatory serial biopsy

PYX-201-101: A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants with Advanced Solid Tumors

• PYX-201: Ab-drug conjugate (anti-EDB+fibronection linked to auristatin), IV, Q3W
• Mandatory on-treatment biopsy + archival tissue <3y old

IMC-F106C-101: A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

• IMC-F106C: monoclonal T cell receptor fused to an antibody against CD3
• Arm A: IMC-F106C monotherapy
• Arm B: IMC-F106C + pembrolizumab
• Arm C: IMC-F106C + chemo (PLD)
• IMC-F106C: IV, QW, intrapatient dose escalation
• Pre-screening for HLA: mandatory for all tumor types
• Pre-screening for PRAME: not mandatory for CM, EC, NSCLC, SCLC, SOC, TNBC and UM, only retrospective testing requested. Mandatory PRAME pre-screening for all other tumor types. 

XB002-101 (JEWEL101): A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors

• ESCC
• Urothelial cancer
• NSCLC (waiting list)
• mCR prostate cancer (waiting list)
• TNBC (triple negative breast cancer) (waiting list)
• Epithelial ovarian carcinoma
• HNSCC
• Pancreatic cancer (waiting list)
• Cervical cancer
• HR+ breast cancer

• ESCC: <= 2L
• Urothelial cancer: <= 3L
• NSCLC: <= 3L
• mCR prostate cancer: min 1 novel hormonal therapy
• TNBC: >1L and <= 3L
• Epithelial ovarian carcinoma: <= 3L
• HNSCC: <= 3L
• Pancreatic cancer: >1L and <= 2L
• Cervical cancer: <= 2L
• HR+ breast cancer: >1L and <= 2L (no limit on endocrine therapy)

• XB002: Ab-drug conjugate (anti-TF antibody linked to a novel N-acyl sulfonamide auristatin), IV, Q3W
• XB002 monotherapy
• TF expression test on archival tissue in local lab, only required for the other solid tumors cohort
• Archival tissue <2y (otherwise fresh biopsy can be used)

JK08.1.01: A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, in Patients with Unresectable Locally Advanced or Metastatic Cancer

• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)
• Cutaneous melanoma
• Clear cell or papillary renal cell carcinoma (RCC)
• Urothelial cancer (UC)
• Head and neck squamous cell cancer (HNSCC)
• Luminal B (ER+, PR-, any HER2 status) or triple-negative breast cancer (TNBC)
• Gastric or gastro-esophageal adenocarcinoma (GC/GEJ)
• Esophageal squamous cell cancer (ESCC)
• Skin squamous cell carcinoma (SCC)
• Pancreatic adenocarcinoma
• Hepatocellular carcinoma (HCC) (Childs-Pugh A or B7 only)
• Colorectal adenocarcinoma (CRC)
• Epithelial ovarian cancer
• Cervical cancer
• Endometrial adenocarcinoma
• Thyroid cancer (follicular or papillary)

• JK08: an IL-15 antibody fusion protein targeting CTLA-4, SC, QW
• JK08 monotherapy
• Pre- and on treatment biopsy for backfill patients

GCT1047-01: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

• PROC (platinum resistant ovarian cancer) (on hold)
• TNBC (triple negative breast cancer) (waiting list)
• EC (endometrium cancer)

• GEN1047: bispecific antibody for B7H4 + CD3
• GEN1047, IV, QW in C1-4, Q3W from cycle 5
• Mandatory fresh biopsy (except when not medically feasible)

Bayer 21820: First-in-human dose-escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of the anti-CCR8 antibody BAY 3375968 as monotherapy and in combination with pembrolizumab in participants with selected advanced solid tumors

• Arm 1A: NSCLC, TNBC, HNSCC, melanoma, other types of skin cancer
• Arm 1B: all solid tumors, except for primary CNS tumors

• BAY3375968: Anti-CCR8 antibody, IV, QW
• Arm 1A: BAY3375968 monotherapy 
• Arm 1B: BAY3375968 + pembrolizumab, Q3W, IV
• Arm 1A: mandatory biopsy
• Arm 1B: no mandatory biopsy

OPTIMIZE-1: An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

• mFOLFIRINOX Q2W IV + mitazalimab Q2W IV 
• Mitazalimab: anti-CD40 antibody
• Archival tissue <28d old or fresh biopsy

• AZD9833 vs standard mono ET
• Min 2 years on adjuvant ET, max. 5 years (+/- CDK4/6 inhibitor)
• Bilateral en multifocal/centric allowed if all lesions are HER2- and ER/PR+
• Tumor tissue required (wait for receipt, but not results)

• Dato-DXd + Durva vs Dato-DXd vs Investigator Choice
• If post-operative radiation: interval <6weeks between end date radiation and randomisation
• If no radiation: interval <16weeks between date breast surgery and randomisation
• Patient must have residual invasive disease and/or axillary lymph nodes after surgery

TACTIVE-U/C4891024: An interventional safety and efficacy Phase 1b/2, open-label umbrella study to investigate tolerability, PK, and antitumor activity of ARV-471 (PF-07850327), an oral Proteolysis Targeting Chimera, in combination with other anticancer treatments in participants aged 18 years and over with ER+ advanced or metastatic breast cancer.

• Max. 2 prior lines in m+ setting:
• <= 1 prior chemo
• <= 2 prior ET
• 1 prior CDK4/6 required (adjuvant allowed)
• No prior experimental ET (SERD, pROTAC, CERAN, SERCA) or elacestrant

ELECTRA/ELA-0121: An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from ER Positive, HER-2 Negative Breast Cancer

• prior therapy in the m+ setting :
• min. 1 ET
• max. 2 chemo regimens
• max. 2 prior prior CDK 4/6 inhibitors, not abemaciclib

C4891001 / Veritac-2: A Phase 3, Randomized, Open-Label, Multicenter Trial Of Arv-471 (Pf-07850327) Vs Fulvestrant In Participants With Estrogen Receptor-Positive, Her2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment For Advanced Disease.

• 1 prior line of CDK4/6 + ET in m+ setting
• Max. 1L of ET in m+ setting in addition to CDK4/6 regimen.
• Last ET must have been given for ≥ 6 months without PD.
• A neoadjuvant/adjuvant treatment is counted as a line for m+ setting if PD on or within 12 months after last dose.
• No prior chemotherapy for advanced/metastatic disease.

VIKTORIA-1/CELC-G-301: A Phase 3, Open-Label, Randomized, Three-Arm Study of Gedatolisib Plus Palbociclib plus Fulvestrant and Gedatolisib Plus Fulvestrant in HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Patients Previously Treated with a CDK4/6 Inhibitor

• Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor
• No prior treatment with fulvestrant, PI3K inhibitor, AKT inhibitor, mTOR inhibitor
• No prior chemotherapy for advanced disease
• Max. 2 prior lines of ET

INAVO121/WO43919: a Phase III, multicenter, randomized, open-label, global study designed to compare the efficacy and safety of inavolisib plus fulvestrant versus alpelisib plus fulvestrant in patients with HR +/HER2 - , PIK3CA-mutated LA/mBC, who progressed during or after CDK4/6i-plus endocrine therapy.

• PIK3CA mutation (can be centrally tested on blood, see protocol for specifications)
• PD during or after CDK4/6 + ET
• Max. 2 prior systemic therapies in m+ setting (1L chemo allowed)
• No prior treatment with: PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the  PI3K/-AKT/-mTOR pathway

AIPAC-003: A randomized, double-blind, placebo-controlled Phase 3 trial testing eftilagimod alpha (soluble LAG-3) in HER2-neg/low metastatic breast cancer patients receiving paclitaxel, following an open-label dose optimization

• Paclitaxel + eftilagimod alpha
• HR+ patients must be ET resistant
• Number of ET does not matter
• TNBC must not be eligible to anti-PD-1 based therapy 
• No prior chemo for MBC 

R4018-ONC-1721: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer 

• At least 1 prior platinum line for which progression

• REGN4018 IV QW as monotherapy OR REGN4018 IV QW + cemiplimab IV Q3W
• Mandatory screening biopsy
• Very intensive study with mandatory hospitalization after the first 3-6 REGN4018 administrations (depending on cohort)
• Very intensive PK sampling

MK4830-002: Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

• New diagnosis
• No prior therapy

• Neoadj: 3 cycles of carbo/paclitaxel + pembro (+ MK4830)
• Interval debulking
• Adj: 3 cycles of carbo/paclitaxel + pembro (+ MK4830)

(IN)CIP-S25470: Cancer in Pregnancy 

• All 

GE-CIP-S62388: Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

• All

Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer 

REGINA

• Regorafenib + nivolumab + short-course radiotherapy
• Intermediate-risk stage II-III 

NCT04503694

Phase 3 study of perioperative Dostarlimab in participants with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer.

219606 / AZUR-2

• Dostarlimab Q3W -IV- 4 cycle > surgery > Dostarlimab Q6W – 6 cycli > FU
• Vs Surgery > SOC capox or folfox > FU
• Randomization 2:1
• Untreated T4N0 or stage III dMMR/MSI-H colon cancer

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma 

GO44479 - IMCODE003

• Arm A: Autogene cevumeran IV + atezolizumab IV Q4W + mFolfirinox
• Arm B: mFolfirinox 
• Randomization 1:1
• Screening occurs in 2 parts:
• Part A before surgery to collect blood and tissue – at least 5 neoepitopes must be identified
• Part B: Main ICF and further screening within 28 and 14 days of enrolment
• Histological confirmed diagnosis of PDAC
• pTNM:  T1-T3, N0-N2, M0 per AJCC 8th ed
• R0 or R1 resection of PDAC
• Absence of spleen; distal pancreatectomy with splenectomy is exclusionary

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer

AT148006

ASPEN-06

• phase 2: ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Trastuzumab  +Ramicirumab + Paclitaxel 
• phase 3:  ALX 148 + Trastuzumab + Ramicirumab+ Paclitaxel vs Ramicirumab + Paclitaxel
• HER2 positive tumor
• Progression on or after prior HER2 directed agent + 5FU or platinum containing regimen

NCT05002127

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 

AMGEN 20210096 FORTITUDE-101

• Bemarituzumab versus placebo +chemotherapy  (folfox 6)
• FGRF2b central testing by IHC
• HER2 positive tumor is exclusion if known

NCT05052801

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen 

DS8201-A-U306

DESTINY-gastric-04

• Trastuzumab Deruxtecan versus Ramicirumab+Paclitaxel
• Centrally confirmed HER2- positive tumor (IHC3+ or IHC 2+)
• Progression on or after first line Trastuzumab-containing regimen

NCT04704934

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation 

MRTX849 

KRYSTAL-10

• MRTX 849 + cetuximab versus chemotherapy
• KRAS G12C mutation
• Disease progression on 1st line

NCT04793958

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

AMGEN 20210098 - FORTITUDE-102

• Bemarituzumab + mFOLOFOX6 + Nivolumab Versus Placebo + mFOLFOX6 + Nivolumab
• No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. 
• FGFR2b overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing
• Prior treatment with (FGF—FGFR pathway is exclusion

NCT05111626

FOLICOLOR Trial: Following therapy response through Liquid Biopsy in metastatic colorectal cancer patients

• Randomized trial: Therapy response CT-scan VS. Liquid Biopsy
• Starting FOLFOX/FOLFIRI +/- EGFR OR +/- VEGF
• Starting Pembrolizumab (MSI high)
• RAS/BRAF mutant/WT or MSI high
• ECOG 0-2
• > 18 years

NALPAC:

A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + Naliri and 5-FU + Nalirinox for metastatic pandreatic ductal adenocarcinoma

• Randomized trial 1:1: 
• Arm A (standard of care arm): nal-IRI + 5-FU/LV (NALIRI)
• Arm B (experimental arm): nal-IRI + 5-FU/LV + OxaliplatinECOG 0-2
• Progression After 1L gemcitabine mono OR gemcitabine/abraxane

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined with Chemotherapy, in Patients with advanced cancers.

ACTUATE  1801

COLIPAN: 

Collection of Liquid Biopsies in Pancancer patients

• Liquid Biopsy collection new diagnoses 
• No NET-tumours

A Randomised, double–blind, placebo-controlled Trial of Aspirin to prevent Recurrence

ASPIRIN

• Aspirin versus placebo
• R0 resection
• >45year
• Stage II-III

Open-label, phase 2 trial of Botensilimab as monotherapy and in combination with Balstilimab or investigator’s choice SOC (regorafenib or trifluridine and tipiracil) for refractory metatstatic colorectal cancer.

PROTOCOL C-800-25

Agenus 

• Arm A + B: Botensilimab (IV) + balstilimab (IV)
• Arm C + D: Botensilimab (IV)
• Arm E: regorafenib (PO) or trifluridine/tipiracil (PO) - PI choice
• Progressed or intolerance on SOC
• Measurable disease per RECIST 1.1
• Tissue to be submitted

Exclusion:

• MSI-H/dMMR tumor
• Liver metastasis > unless definitively treated at least 6 months prior enrolment
• prior treatment with regorafenib or trifluridine/tipiracil
• Ascites requiring frequent paracenteses

A randomized Phase 2 Study of ompenaclid versus placebo in combination with FOLFIRI plus bevacizumab in patients with previously treated RAS mutant advanced or mCRC

RGX 202-002

• Ompenaclid versus placebo (PO) BID + folfiri + bevacizumab (IV) Q2W
• Randomization 1:1
• RAS mutated 
• Progression after receiving 1 oxaliplatin containing regimen
• dMMR/MSI-H CRC must also have received prior pembrolizumab or an FDA/EU approved PD-1/PD-L1 inhibitor
• Measurable disease per Recist 1.1

Personalized multimodal treatment for resectable esophageal cancer by detecting minimal residual disease using circulating tumor DNA: a multicentric prospective study

Group 1: Patients undertaking primary resection (surgery or endoscopic) with no neoadjuvant chemotherapy or chemoradiation.

Group 2: Patients receiving neoadjuvant chemoradiotherapy, followed by resection and observation (no adjuvant immunotherapy). A subgroup of patients will undertake adjuvant immunotherapy and will constitute Group

Group 3: Patients undertaking neoadjuvant chemoradiotherapy, resection and adjuvant immunotherapy.

• Sponsor UZ Leuven. Prospective collection of liquid biopsies (additional tubes at time of routine lab assessments), retrospective retrieval of leftover tissue samples, and collection of standard clinical data in an electronic database are study-related procedures.

SARTOX

Not applicable

• Association between sarcopenia and chemotoxicity in older patients with gastro-intestinal tumors

STEREOPAC

Not applicable

• Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma
• Sponsor: Erasme University Hospital

A study of Tucatinib + Trastuzimab + mFOLFOX6 versus standard of care treatment in 1ste line HER2+ mCRC.

SGNTUC-029 / MOUNTAINEER-03

1st line

• Tucatinib +Trastuzumab+mFOLFOX6
  vs
• mFOLFOX6 +/- Bevacizumab or Cetuximab
• Tissue available: max 35 days old prior start of study
• HER2+ disease (IHC3+ or IHC2+/ISH+) > analyzed in a central lab 
• RAS WT  > analyzed local or central
• Measurable disease per RECIST1.1 criteria
• Prior anti-HER2 therapy is exclusion
• Adjuvant therapy is allowed if completed > 6 months prior enrollment

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic HCC.

IMbrave152 / CO44668

1L

• Arm A: Atezolizumab + bevacizumab + Tiragolumab - IV Q3W
• Arm B: Atezolizumab + bevacizumab + placebo - IV Q3W
• Randomization 1:1
• Measurable disease per Recist 1.1
• Child-Pugh A < 7 d of randomization

Phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety Rego-Pembro versus TACE or TARE for the first-line treatment of HCC 

TRIO 041 / REPLACE studie

1ste line

• Regorafenib PO + pembrolizumab IV Q6W vs TACE or TARE
• Randomization 1:1
• Intermediate-stage HCC/beyond up-to-seven criteria / Child-Pugh Class A
• No contraindication to intra-arterial treatment
• Measurable disease per Recist 1.1
• No prior therapy for HCC
• Fibrolamellar HCC, sarcomatoid HCC or mixed HCC / cholangiocarcinoma / clinically significant ascites are excluded

A study of on-treatment ctDNA changes in chemo-refractory colorectal cancer patients

COPERNIC

>= 3L

• Collection of blood samples at pre-defined time points for ctDNA testing.
• Collection of archived tumour tissue to perform genomic characterisation

NCT05487248

A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma

BALLAD 

1L

• Group 1: adjuvant chemotherapy versus observation
• Group 2: monotherapy (5-FU/FA or capecitabin) versus combined therapy (5FU/FA orcapecitabin +oxaliplatin)

Efficacy and safety of SCRT versus TNT in older patients with locally advanced rectal cancer

SHAPERS

1L

• Stage III or high-risk stage II rectal cancer, ≥ 70 years
• Randomisation (1:1) to short-course radiotherapy (SCRT) or total neoadjuvant therapy (TNT)
• QOL-questionnaires

NCT06052332

A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer 

1L

• Randomized trial with Dostarlimab mono VS adjuvant FOLFOX or CAPEOX or Watch and Wait
• Dostarlimab 500mg Q3W for 4 cycles followed by surgery and additional 6 cycles of dostarlimab 1000mg Q6W

OR

• Surgery followed by SOC (FOLFOX or CAPEOX or WATCH and Wait)
• Tumor with dMMR or MSI-H

NCT05855200

WT IL15 DC vaccination Trial: First-in-human interleukin-15-transpresenting Wilms’ tumor protein 1-targeting autologous dendritic cell vaccination in cancer patients

>= 2L; PD on last therapy not needed

• Vaccination with 6 IL-15-Transpresenting WT1-targeted DC vaccines after leukapheresis

NCT05964361

JZJB/LIBRETTO-531: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer 

Thyroid

• Crossover possible
• Patients from 12 yo

ELEVATE: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

SCCHN:

• oropharynx
• oral cavity
• hypopharynx
• larynx

• metastatic or unresectable, locally recurrent
• Phase 2 cohort 1: 1L
• • arm A: magrolimab + pembrolizumab + platinum + 5-FU
  • arm B: pembrolizumab + platinum + 5-FU
  • arm C: magrolimab + zimberelimab + platinum + 5-FU

COLIPAN: collection of Liquid Biopsies in Pancancer patients

H&N plaveiselcelCa

• Liquid Biopsy collection new diagnoses 
• NO NET-tumours

MS202359_002 XRay Vision: A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy

Resected LA SCCHN, high risk, cisplatin-ineligible participants

• Start of treatment within 4-8 weeks after surgery, no residual disease and no metastasis for cisplatinum ineligible patients
• HPV negative needs to have pIII or pIV OR HPV positive = smoker > 25PJ and pT3N2 or pT4N2
• Combination of RT and Xevinapant/placebo 200mg
• RT will be given for 5 days in 7 for 6,5 weeks in 33 fractions
• Xevinapant/placebo will be given during 2 weeks of a 3-week-cycle

Hyperlynx: A Single Arm, Open label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

Patients with unresected LA SCCHN (stage III, IVA or IVB) 

• For OPC patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry
• Weekly cisplatine for 7 weeks
• Radiotherapy 5 days per week for 7 weeks
• Xevinapant 14 days per cycle of 21days for 6 cycles in total

• Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
• No Prior radiation or chemotherapy
• Total or subtotal resection
• No corticosteroid treatment ≤ 1 week before
• WT1 mRNA-loaded DC vaccination + CRT (temozolomide)

• ≥ 2 bone metastases
• Ongoing androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy
• Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
• ARM A: Enzalutamide
• ARM B: Ra223 + Enzalutamide

• HR NMIBC: recurrent T1, high-grade Ta and/or CIS
• Persistent: remains present within 3 months (-2 weeks) to 6 months (+4 weeks) after start of BCG induction (note: persistent T1 nog eligible)
• Recurrent: reappearance of HR NMIBC after achieving a CR or tumor free state within 6 months after start of BCG induction. The recurrence must be within 24 months of last exposure to BCG (+56 days).
• Prior cystoscopy/TURBT within 12 weeks prior to randomization.
• For recurrent T1: restaging TURBT between 14-56 days prior to randomization.

• Liquid Biopsy collection new diagnoses 
• No NET-tumours 

• Prior SOC
• Anti-PD-(L)1 as last line for which progression within 12 weeks from last dose

• randomization between IFX-1 monotherapy (IV) or IFX-1 with pembrolizumab
• mandatory baseline biopsy 

NSCLC stage IV and healty subjects

• Adeno and squamous
• Healthy subjects:
• never smoked or stopped >20y and no COPD
• smoker >20 PY
• Blood and urine collection
• Tissue from patients only
• Sample collection before start 1L

NSCLC stage III

• PD-L1 TC ≥ 1% assessed centrally during pre-screening while on cCRT
• Must have not progressed following cCRT
• Must have received at least 2 cycles of chemotherapy
• Total dose of radiation of 60 Gy ± 10% 

NSCLC stage IB-IIIA, RET fusion

• RET fusion on PCR/NGS
• Must have received definitive locoregional therapy
• Max 10 weeks between local therapy and randomization if no chemo
• Max 26 weeks between local therapy and randomization if adj chemo
• Crossover possible

NSCLC stage IIIB-IV, KRAS G12C

• KRAS G12C
• Cohort 1: PD-L1 TPS <1%
• Cohort 2: PD-L1 TPS ≥1% (CLOSED)
• Unresectable or metastatic
• Squamous or nonsquamous

NSCLC stage I-II, EGFRm

• T1a to T3N0M0
• Medically inoperable or surgery refusal
• Central or peripheral lesions are eligible
• (Meta)synchronous NSCLC tumors are allowed (max 2)
• No durvalumab
• Ex19del or L858R

Malignant Pleural Mesothelioma

• High-Dose RT, Lung-sparing multimodality therapy
• R0-R1 resection
• >18 years
• WHO 0-2
• DLCO > 40%

SCLC limited - extensive stage

• Stage I-IV
• Randomization within 16 weeks after last chemo
• Immunotherapy continuing adjuvant is allowed
• No brain metastases and no prior brain RT

NSCLC adenoCa,

NSCLC plaveiselcelCa

• Liquid Biopsy collection new diagnoses 
• No NET tumors 

NSCLC stage III-IV, PD-L1 high

• PD-L1-high (TC/TPS >=50%) by 22C3 or SP263
• smoked >100 cigarettes in a lifetime (former/current)
• squamous and non-squamous

Open cohorts:

• Pembrolizumab monotherapy
• Dostarlimab monotherapy
• Substudy 1B: Dostarlimab + Belrestotug 400mg
• Substudy 2A: Dostarlimab + Belrestotug 400 mg + GSK6097608 1400 mg

SCLC limited - extensive stage

• prior platinum chemotherapy +/- anti-PD-(L)1 (>=70% of patients included must have been pretreated with anti-PD(L)1
• last dose of platinum to PD >= 30 days
• if CNS metastases: pretreated, stable and asymptomatic
• limited-stage disease who are candidates for local/regional therapy, must have been offered that option and completed/refused it

NSCLC stage III-IV, EGFRm

• At least 1 sensitising EGFR mutation: exon19 deletion, L858R mutation and/or T790M
• Osimertinib as most recent, in 1L or 2L
• Chemotherapy and immunotherapy naïve in metastatic setting
• No other prior third-generation EGFR-TKI
• MET overexpression and/or amplification assessed in central lab

NSCLC

• Blood collection in inoperable/relapsed NSCLC starting ICI treatment 
• 1st sample collection before start therapy

NSCLC stage III-IV

• 1 prior platinum chemotherapy + 1 checkpoint inhibitor (+ targeted therapy if indicated)
• c-Met overexpression assessed centrally
• No prior cMET therapy
• Treated brain mets are eligible

NSCLC stage III-IV

• non-squamous
• prior platinum chemo + anti-PD-(L)1 (+ targeted therapy if indicated, but no EGFR or ALK)
• fresh biopsy

NSCLC stage IIIb-IV

• non-squamous
• actionable molecular alterations allowed
• prior platinum chemo + anti-PD-(L)1 (+ targeted therapy if indicated)