Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

Phase 2 Active not recruiting 110 enrolled Cardiff Oncology Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.

Timeline

Start: 2024-02-27
Primary completion: 2026-11
Completion: 2027-01

Publications

Ahn DH, Ridinger M, Cannon TL, Mendelsohn L, Starr JS, Hubbard JM, Kasi A, Barzi A, Samuelsz E, Karki A, Subramanian RA, Yemane D, Kim R, Wu CC, Croucher PJP, Smeal T, Kabbinavar FF, Lenz HJ. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial. J Clin Oncol. 2025 Mar;43(7):840-851. doi: 10.1200/JCO-24-01266. Epub 2024 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Onvansertib	Small molecule	20 mg	Oral
Subject	Onvansertib	Small molecule	30 mg	Oral
Background	Bevacizumab	Monoclonal antibody	—	Intravenous
Background	Irinotecan	Small molecule	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	Oxaliplatin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

Summary

Timeline

Publications

Drugs

Indications