NCT07300891

T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherapy) for Refractory Solid Cancer Patients Unexposed to Immunotherapy

Not yet recruiting Phase 2 Last updated 24 December 2025

What this trial tests

Phase 2 trial testing Tisleizumab(BGB-A317) in Refractory Solid Cancer Patients Unexposed to Immunotherapy in 72 participants. Not yet recruiting.

Timeline

31 January 2026

Primary endpoint
31 January 2027

31 January 2028

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	31 January 2026
Primary completion	31 January 2027
Estimated completion	31 January 2028

Drugs / interventions tested

• Tisleizumab(BGB-A317) — full drug profile →

Conditions studied

• Refractory Solid Cancer Patients Unexposed to Immunotherapy — all drugs for Refractory Solid Cancer Patients Unexposed to Immunotherapy →

Sponsor

Samsung Medical Center

Who can join

20 and older, any sex, with Refractory Solid Cancer Patients Unexposed to Immunotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.