NCT06824363EARLY_PHASE1Recruiting

ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu

University of California, Irvine

Start Date

5/25/2026

Completion Date

7/1/2028

Summary

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Non metastatic GEC including locally advanced unresectable * Treatment naïve * Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES * MSI-Stable or pMMR * Age ≥ 18 years * Body weight \> 66 pounds * ECOG ≤ 2 * Repeat biopsy feasible * No clinically significant autoimmune disease Exclusion Criteria: * Patients with known metastatic disease * Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma * Patients with uncontrolled autoimmune disease per investigator discretion * Inability or refusal to undergo biopsy procedures to obtain tissue samples

Interventions

DRUG

Tremelimumab

DRUG

Durvalumab

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Conditions

Solid Tumor, AdultMalignant Solid TumorStomach AdenocarcinomaEsophageal Adenocarcinoma

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California 92868

United States