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New treatment option for Solid Tumor, Adult
Official title ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
ClinicalTrials.gov ID: NCT06824363
What this study is testing
What is Tremelimumab?
Tremelimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.