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

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. Expansi

Trial Details

NCT ID
NCT05187182
Phase
PHASE1
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • CA-4948
  • Nivolumab
  • Pembrolizumab
  • Trastuzumab
  • mFOLFOX7
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach, gastroesoph…
  • Measurable or evaluable disease defined by RECIST 1.1.
  • Lesions amenable to research biopsy. This criteria can be waived by the PI after documented discussion with the treating physician.
  • Known HER2 status if histology is adenocarcinoma prior to enrollment; results from local CLIA laboratory is acceptable.

For full eligibility, visit ClinicalTrials.gov.

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