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

NCT06824363 | Not Yet Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 6069UCI 23-173
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Completing Study Treatment

  Percentage of Subjects Completing the Study Treatment

  2 Years

• Percentage of Subjects Completing Post-Treatment Biopsy

  Percentage of Subjects Completing the Post-Treatment Biopsy

  2 Years

Secondary Outcomes (4)

• Percent Change in the Proportion of Intra Tumoral Effector T-cells

  2 years

• Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.

  2 years

• Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events

  2 years

• Comparison of T-Cell Infiltration in Various Tumor Mutations

  2 years

Study Arms (1)

Tremelimumab and Durvalumab

EXPERIMENTAL

Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1

Drug: Tremelimumab; Drug: Durvalumab

Interventions

Tremelimumab DRUG

single dose, 300mg IV, day 1

Tremelimumab and Durvalumab

Durvalumab DRUG

single dose, 1500 mg IV, day 1

Tremelimumab and Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

tremelimumab; durvalumab

Study Officials

• Farshid Dayyani

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Associate Clinical Professor, Department of Medicine, Division of Hematology, Oncology

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)