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

Recruiting now · Early Phase 1

Conditions studied: Solid Tumor, Adult, Malignant Solid Tumor, Stomach Adenocarcinoma, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06824363

Run by

University of California, Irvine

People needed

34

Starts

2026-05-25

Expected to finish

2028-07-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (enrolling)

Full record on ClinicalTrials.gov

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