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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test a new treatment approach for patients with specific types of stomach and esophageal cancers that have a mutation in a gene called ARID1A. The study aims to see if a single dose of a special type of medicine, called dual immune checkpoint inhibitors, can help increase the number of immune cells (T cells) in the tumors, which may help the body fight the cancer better. It is important to note that this trial is for patients who have not received any prior treatment for their cancer and whose disease has not spread to other areas of the body.

To be eligible for this trial, participants must be at least 18 years old, weigh more than 66 pounds, and have a confirmed diagnosis of esophageal or stomach adenocarcinoma with the ARID1A mutation. They should also be willing to undergo biopsy procedures to collect tissue samples. Patients with certain autoimmune diseases or known metastatic disease (cancer that has spread) cannot participate. If enrolled, participants can expect to receive the investigational treatment and will be closely monitored throughout the study to assess its effects. This trial is currently not yet recruiting participants, but it represents an important step in exploring new options for treating these types of cancers.

Gender

ALL

Eligibility criteria

• 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