ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
NCT06824363 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-01-30
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.
Conditions
- Solid Tumor, Adult
- Malignant Solid Tumor
- Stomach Adenocarcinoma
- Esophageal Adenocarcinoma
Interventions
- DRUG
-
Tremelimumab
single dose, 300mg IV, day 1
- DRUG
-
single dose, 1500 mg IV, day 1
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Farshid Dayyani · Chao Family Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-01-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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