RecruitingPhase 1NCT05187182

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

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

Sponsor

Washington University School of Medicine

Enrollment

42 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastric Cancer Esophagus Cancer Stomach Cancer

Summary

This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called CA-4948 in combination with a standard chemotherapy regimen (FOLFOX) and an immunotherapy drug (a PD-1 inhibitor), with or without trastuzumab, as first-line treatment for advanced stomach or esophageal cancer. **You may be eligible if...** - You are 18 or older with advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer - You have not yet received systemic treatment for your advanced cancer - Your cancer's HER2 status has been tested - You are in good general health (ECOG 0 or 1) - Your liver, kidney, heart, and bone marrow function are within acceptable ranges **You may NOT be eligible if...** - You have previously received systemic therapy for advanced/unresectable disease - You have active brain metastases (treated and stable metastases may be allowed) - You have active autoimmune disease requiring systemic treatment - You are currently pregnant or breastfeeding - You have significant bleeding risk or are on blood thinners - You have a history of organ or stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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