T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherap… (NCT07300891) | Clinical Trial Compass
Not Yet RecruitingPhase 2
T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherapy) for Refractory Solid Cancer Patients Unexposed to Immunotherapy
72 participantsStarted 2026-08
Plain-language summary
This is a Phase 2, single-arm, multicenter study, evaluating the anti-tumor efficacy of tumor-infiltrating lymphocyte (TIL) directed tislelizumab monotherapy (also known as BGB-A317) for refractory solid tumors in approximately 72 patients with centrally confirmed T cell inflamed GEP score ≥ 0.857, who have not been previously exposed to immunotherapy.
All patients must provide a tumor specimen for T cell inflamed GEP assessment. Archived tissue slide collected within 2 years from the first dose of study drug must be provided.
This study will include a Screening Period, a Treatment Period, and a Follow-Up Period. All patients will complete up to 28 days of screening. During the Treatment Period, patients will receive tislelizumab 200 mg fixed dose once every 3 weeks by intravenous (IV) administration until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
After treatment discontinuation, patients will be follow-up for disease progression and survival status until death, withdrawal of consent, or study closure, whichever occurs first.
The end of study will be the timepoint when the final data for the study were collected. Additionally, the Investigator Sponsor has the right to terminate this study at any time.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged ≥ 20 years at the time of informed consent.
. Patients with histologically- or cytologically confirmed advanced or metastatic solid tumor who are no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of site physicians, no such treatment is available or indicated according to local or international guidelines.
. Centrally confirmed T cell inflamed GEP score ≥ 0.857 assessed by RNA sequencing. For baseline T cell inflamed GEP, an archived tissue sample collected within 2 years from the first dose of study drug must be provided. T cell inflamed gene expression profiling will be assessed at a central laboratory. Patients who have at least 1 target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) Guideline Ver. 1.1 as confirmed by imaging within 28 days before first dose of study drug.
. ECOG Performance Status Score 0 or 1.
. Patients with a life expectancy of at least 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab
Timeframe: From enrollment to the end of treatment at 30days(+/-7)
. Patients with adequate hematological and biological function as indicated by the following screening laboratory values:
Exclusion criteria
. Patients aged ≥ 20 years at the time of informed consent.
. Patients with histologically- or cytologically confirmed advanced or metastatic solid tumor who are no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of site physicians, no such treatment is available or indicated according to local or international guidelines.
. Centrally confirmed T cell inflamed GEP score ≥ 0.857 assessed by RNA sequencing. For baseline T cell inflamed GEP, an archived tissue sample collected within 2 years from the first dose of study drug must be provided. T cell inflamed gene expression profiling will be assessed at a central laboratory. Patients who have at least 1 target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) Guideline Ver. 1.1 as confirmed by imaging within 28 days before first dose of study drug.
. ECOG Performance Status Score 0 or 1.
. Patients with a life expectancy of at least 3 months.
. Patients with adequate hematological and biological function as indicated by the following screening laboratory values:
. Patients with solid tumors from multiple primary origin (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years).
. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.