16 completed, 10 recruiting, 10 terminated, 2 active not recruiting. 42 Phase 1, 12 Phase 2.
Follow FOLFIRI: new trials by email Literature Review of FOLFIRI trials Research Report on FOLFIRI
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma GDC-7035, Panitumumab, mFOLFOX6 - Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma | Phase 1 | Not yet recruiting | Genentech, Inc. | 388 | 2026-10-31 | 2026-10-13 |
| EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer EMB-01, Irinotecan, TAS-102 - Unresectable/Metastatic Colorectal Cancer | Phase 1 | Recruiting | Shanghai EpimAb Biotherapeutics Co., Ltd. | 120 | 2026-09-30 | 2026-10-16 |
| A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation KST-6051, Gemcitabine/nab-paclitaxel, Cetuximab - KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) | Phase 1 | Recruiting | Kestrel Therapeutics, Inc. | 545 | 2026-04-21 | 2026-10-15 |
| Trial of ProAgio in Advanced/Metastatic Colorectal Cancer ProAgio, FOLFIRI, Bevacizumab - Advanced Colorectal Cancer, Metastatic Colorectal Cancer | Phase 1 | Suspended | University of Alabama at Birmingham | 27 | 2025-07-17 | 2026-10-02 |
| Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) FLOT, FOLFOX, FOLFIRI - Gastroesophageal Adenocarcinoma | Phase 1 | Recruiting | University of California, Irvine | 20 | 2025-06-27 | 2026-03-10 |
| A Study of PHST001 in Advanced Solid Tumors PHST001, Paclitaxel, Topotecan - Advanced Solid Tumors, Ovarian Cancer | Phase 1 | Recruiting | Pheast Therapeutics | 426 | 2025-03-31 | 2026-10-05 |
| A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers JNJ-89402638, Bevacizumab, FOLFOX - Colorectal Neoplasms, Gastrointestinal Neoplasms | Phase 1 | Recruiting | Janssen Research & Development, LLC | 260 | 2024-10-15 | 2026-11-03 |
| A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation INCB161734, Cetuximab, Retifanlimab - Solid Tumors | Phase 1 | Recruiting | Incyte Corporation | 710 | 2024-01-04 | 2026-07-22 |
| A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors INCA33890, bevacizumab, FOLFIRI - Solid Tumors, Advanced Solid Tumors | Phase 1 | Recruiting | Incyte Corporation | 570 | 2023-07-24 | 2026-07-23 |
| A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors ST316, FOLFIRI regimen & bevacizumab, Fruquintinib - Colon Cancer, Metastatic Colon Cancer | Phase 1 | Active not recruiting | Sapience Therapeutics | 130 | 2023-06-05 | 2026-07-22 |
| Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies S241656, FOLFOX6/FOLFOX7, FOLFIRI - Non-small Cell Lung Cancer, Histiocytic Neoplasm | Phase 1 / Phase 2 | Recruiting | Institut de Recherches Internationales Servier | 554 | 2023-04-18 | 2026-10-13 |
| Switch Maintenance in Pancreatic ZIMBERELIMAB, DOMVANALIMAB, APX005M - Pancreatic Cancer, Adenocarcinoma of the Pancreas | Phase 1 / Phase 2 | Suspended | James Cleary, MD, PhD | 46 | 2022-11-30 | 2026-06-04 |
| Study of RP-6306 With FOLFIRI in Advanced Solid Tumors RP-6306 (oral PKMYT1 inhibitor) - Advanced Solid Tumor | Phase 1 | Terminated | Debiopharm International SA | 38 | 2022-08-09 | 2025-12-05 |
| A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers BI 905711, FOLFIRI, Bevacizumab - Gastrointestinal Cancer, Metastatic | Phase 1 | Completed | Boehringer Ingelheim | 13 | 2021-11-24 | 2025-02-19 |
| A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) Inavolisib, Bevacizumab, Cetuximab - Metastatic Colorectal Cancer | Phase 1 | Recruiting | Hoffmann-La Roche | 542 | 2021-10-22 | 2026-10-09 |
| Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers Aplitabart (IGM-8444), FOLFIRI, Bevacizumab (and approved biosimilars) - Solid Tumor, Colorectal Cancer | Phase 1 | Terminated | IGM Biosciences, Inc. | 272 | 2020-09-23 | 2025-03-28 |
| TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers TTX-080, pembrolizumab, cetuximab - Cancer | Phase 1 | Active not recruiting | Tizona Therapeutics, Inc | 240 | 2020-07-14 | 2026-09-11 |
| Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment Selinexor 100 mg, Docetaxel, Pembrolizumab - Non-Small Cell Lung Carcinoma (NSCLC), Colorectal Cancer (CRC) | Phase 1 / Phase 2 | Completed | Karyopharm Therapeutics Inc | 80 | 2020-02-09 | 2026-10-09 |
| Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma FOLFIRI, FOLFIRINOX, TriSalus Infusion System - Pancreatic Adenocarcinoma | Phase 1 | Withdrawn | Roger Williams Medical Center | 2019-12-23 | 2021-06-01 | |
| Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation Onvansertib, Bevacizumab, FOLFIRI - Metastatic Colorectal Cancer, KRAS Gene Mutation | Phase 1 / Phase 2 | Completed | Cardiff Oncology | 68 | 2019-06-24 | 2025-03-04 |
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Colorectal Neoplasms (29) · Neoplasm Metastasis (6) · Colonic Neoplasms (5) · Lung Neoplasms (5) · Neoplasms (5) · Ovarian Neoplasms (4) · Breast Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (3) · Endometrial Neoplasms (3) · Gastrointestinal Neoplasms (3) · Pancreatic Neoplasms (3) · Rectal Neoplasms (3) · Stomach Neoplasms (3) · Carcinoma, Renal Cell (2) · Cholangiocarcinoma (2)
AbbVie (3) · EMD Serono (2) · Eisai Inc. (2) · Incyte Corporation (2) · OncoMed Pharmaceuticals, Inc. (2) · 4SC AG (1) · AbbVie (prior sponsor, Abbott) (1) · Amgen (1) · Bionomics Limited (1) · Boehringer Ingelheim (1) · Cardiff Oncology (1) · Celyad Oncology SA (1) · Daiichi Sankyo (1) · Debiopharm International SA (1) · Genentech, Inc. (1)
United States (32) · Spain (13) · Australia (8) · France (6) · Italy (6) · Japan (6) · Belgium (5) · Canada (5) · South Korea (5) · United Kingdom (5) · China (4) · Denmark (3) · Germany (3) · Israel (2) · Netherlands (2)
Harish Dave (2) · Abi Vainstein-Haras (1) · Eric Humke, MD, PhD (1) · Farshid Dayyani, MD,PhD (1) · James Cleary, MD, PhD (1) · Josep Tabernero, MD, PhD (1) · Louie Naumovski, MD (1)
PMID 25627002, PMID 25772756, PMID 34315767, PMID 34646387, PMID 35191428, PMID 35467243, PMID 36720090, PMID 38036720, PMID 38231047, PMID 39475591, PMID 40016550
2023 (2), 2009 (1), 2015 (1), 2016 (1), 2018 (1), 2025 (1)