ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
Part of paid clinical trials in Orange, California.
- Sponsor
- University of California, Irvine
- Study ID
- NCT06824363
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Esophageal Adenocarcinoma
- Malignant Solid Tumor
- Solid Tumor, Adult
- Stomach Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUGsingle dose, 300mg IV, day 1
- Durvalumab — DRUGsingle dose, 1500 mg IV, day 1
Study Details
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 Dates
- Start date
- Apr 30, 2026
- Status verified
- Jan 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 34 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Tremelimumab and DurvalumabTremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
Primary Outcome Measure
Percentage of Subjects Completing Study Treatment [ Time Frame: 2 Years ]
Central Contacts
- Chao Family Comprehensive Cancer Center University of California, Irvine1-877-827-8839
- University of California Irvine Medical
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Orange | California | 92868 | - |
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