Phase 1 Study of CA-4948 Emavusertib with FOLFOX Plus Bevacizumab as First Treatment for Advanced or Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the side effects and optimal dose of CA-4948 emavusertib when given with fluorouracil, leucovorin, oxaliplatin FOLFOX, and bevacizumab for patients with metastatic colorectal cancer. This phase I trial aims to assess safety, tolerability, and anti-tumor activity of this combination as first-line treatment in patients with advanced or metastatic non-operable colorectal cancer. The study also explores genetic markers and biological effects of CA-4948 in tumor samples. Patients join one of two groups receiving CA-4948 orally twice daily on days 1-14 of each 14-day cycle. Group A starts bevacizumab intravenously on day 1 of cycle 1, while Group B begins bevacizumab on day 1 of cycle 2. Both groups receive oxaliplatin, leucovorin, and fluorouracil intravenously on day 1 of each cycle. Treatment continues for up to 2 years unless disease progression or unacceptable side effects occur. After 2 years, continued treatment is possible with study chair approval. Participants undergo regular blood draws and imaging scans like CT, MRI, or PETCT throughout the trial, with optional tumor biopsies. After finishing treatment, they have follow-up visits at 30 days and then every 3 months for up to 12 months to monitor response and safety. The study measures dose-limiting toxicities, treatment side effects, tumor response, progression-free survival, overall survival, and molecular changes related to treatment.

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer