Phase 1 Study of CA-4948 Combined With FOLFOX and PD-1 Inhibitors, With or Without Trastuzumab, for Untreated Advanced Gastric and Esophageal Cancer

What this Trial Is About

Researchers are evaluating the safety and dosing of CA-4948 combined with FOLFOX chemotherapy and PD-1 inhibitors, with or without trastuzumab, in adults with untreated, unresectable gastric, gastroesophageal junction, or esophageal cancer. This phase I trial aims to find the best dose of CA-4948 in combination with these treatments and to assess their safety in patients with HER2 positive or negative cancers. The study includes a Dose Escalation phase where different doses of CA-4948 are tested with FOLFOX and nivolumab to determine the recommended dose. Dose Expansion follows with two groups Cohort A receives CA-4948, FOLFOX, and nivolumab for HER2 negative patients, while Cohort B receives CA-4948 with FOLFOX, pembrolizumab, and trastuzumab for HER2 positive patients. Treatments are given in 14-day cycles, with CA-4948 taken orally twice daily and other drugs administered intravenously according to schedule. Participants will be monitored for safety through tracking adverse events up to 30 days after treatment completion, which is estimated to take about 15 months. Researchers will measure treatment responses, progression-free survival, overall survival, and other outcomes over time. Study visits include drug administration, laboratory tests, imaging, and biopsies when possible. The total study duration varies by participant, with close follow-up to evaluate treatment effects and safety.

CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer