Solid Tumor, AdultEarly Phase 1NCT06824363
ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
A Early Phase 1 study testing Tremelimumab and Durvalumab in people with Solid Tumor, Adult and Malignant Solid Tumor, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Malignant Solid Tumor, Stomach Adenocarcinoma
- What is being tested?
- Tremelimumab and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2026to Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ECOG ≤ 2
- Repeat biopsy feasible
- No clinically significant autoimmune disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Farshid Dayyani, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: 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
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
- Being tested
- Tremelimumab, Durvalumab
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
single dose, 300mg IV, day 1
DurvalumabDrug
single dose, 1500 mg IV, day 1
| Study group | Role | What they receive |
|---|---|---|
| Tremelimumab and Durvalumab | Experimental | Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1 Receives: Drug: Tremelimumab; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Completing Study Treatment
Percentage of Subjects Completing the Study Treatment
Measured: 2 Years
Percentage of Subjects Completing Post-Treatment Biopsy
Percentage of Subjects Completing the Post-Treatment Biopsy
Measured: 2 Years
Secondary outcomes (4)
Percent Change in the Proportion of Intra Tumoral Effector T-cells
Assessment of Effects on Tumor Microenvironment Composition based on the percent change in the proportion of intra tumoral effector T-cells (CD3/CD8) at 2-6 weeks post single dose of STRIDE regiment compared to that at baseline
Measured: 2 years
Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.
Assessment of effects on circulating cytokine from whole blood collection at baseline and after receiving Tremelimumab and Durvalumab. Blood samples will be used to perform a 96-cytokine-discovery assay.
https://www.evetechnologies.com/product/new-human-cytokine-chemokine-96-plex-discovery-assay-array-hd96/
Measured: 2 years
Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events
Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0
Measured: 2 years
Comparison of T-Cell Infiltration in Various Tumor Mutations
Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start25 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farshid Dayyani, University of California, Irvine
- Investigators
- Farshid Dayyani, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824363
- Sponsor's protocol ID
- 6069
- Other IDs
- UCI 23-173
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06824363
- Acronym / sponsor ID
- 6069
- Conditions
- Solid Tumor, Adult, Malignant Solid Tumor, Stomach Adenocarcinoma, Esophageal Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tremelimumab and Durvalumab | Experimental | Drug: Tremelimumab, Drug: DurvalumabTremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tremelimumabsingle dose, 300mg IV, day 1 | Drug | Tremelimumab and Durvalumab |
| Durvalumabsingle dose, 1500 mg IV, day 1 | Drug | Tremelimumab and Durvalumab |
Primary outcome
Percentage of Subjects Completing Study Treatment
Time frame: 2 Years
Percentage of Subjects Completing the Study Treatment
Percentage of Subjects Completing Post-Treatment Biopsy
Time frame: 2 Years
Percentage of Subjects Completing the Post-Treatment Biopsy
4 secondary outcomes
Percent Change in the Proportion of Intra Tumoral Effector T-cells
Time frame: 2 years
Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.
Time frame: 2 years
Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events
Time frame: 2 years
Comparison of T-Cell Infiltration in Various Tumor Mutations
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Farshid Dayyani principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tremelimumab and Durvalumab in people with Solid Tumor, Adult and Malignant Solid Tumor, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Completing Study Treatment (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.