Trials / Not Yet Recruiting
Not Yet RecruitingNCT06824363
ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tremelimumab | single dose, 300mg IV, day 1 |
| DRUG | Durvalumab | single dose, 1500 mg IV, day 1 |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-01-01
- Completion
- 2028-07-01
- First posted
- 2025-02-13
- Last updated
- 2026-01-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06824363. Inclusion in this directory is not an endorsement.