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

NCT07300891 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PAN-IO-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Refractory Solid Cancer Patients Unexposed to Immunotherapy

Outcome Measures

Primary Outcomes (1)

• ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab

  ORR is defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by investigator using RECIST v1.1

  From enrollment to the end of treatment at 30days(+/-7)

Secondary Outcomes (11)

• ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.955 treated with Tislelizumab.

  From enrollment to the end of treatment at 30days(+/-7)

• ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 1.058 treated with Tislelizumab.

  From enrollment to the end of treatment at 30days(+/-7)

• OS in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.

  From enrollment to the end of treatment at 30days(+/-7)

• PFS in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857treated with Tislelizumab.

  From enrollment to the end of treatment at 30days(+/-7)

• CBR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857treated with Tislelizumab.

  From enrollment to the end of treatment at 30days(+/-7)

Study Arms (1)

Tislelizumab(BGB-A317)

EXPERIMENTAL

Drug: Tisleizumab(BGB-A317)

Interventions

Tisleizumab(BGB-A317) DRUG

T cell inflamed GEP score

Tislelizumab(BGB-A317)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥ 1.5×109/L
• Platelets ≥ 75×109/L
• Hemoglobin ≥ 9g/dL or ≥ 5.6 mmol/L (Note: Criteria must be met without a transfusion within 14 days of obtaining the sample)
• Calculated creatinine clearance ≤ 1.5×upper limit of normal (ULN), or estimated GFR ≥ 60 mL/min by Cockcroft-Gault formula
• Serum total bilirubin ≤ 1.5×ULN (total bilirubin must be \< 3×ULN for patients with Gilbert's syndrome)
• Aspartate aminotransferase (AST) and ALT ≤ 3×ULN OR ≤ 5×ULN for patients with liver metastases

You may not qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥ 1.5×109/L
• Platelets ≥ 75×109/L
• Hemoglobin ≥ 9g/dL or ≥ 5.6 mmol/L (Note: Criteria must be met without a transfusion within 14 days of obtaining the sample)
• Calculated creatinine clearance ≤ 1.5×upper limit of normal (ULN), or estimated GFR ≥ 60 mL/min by Cockcroft-Gault formula
• Serum total bilirubin ≤ 1.5×ULN (total bilirubin must be \< 3×ULN for patients with Gilbert's syndrome)
• Aspartate aminotransferase (AST) and ALT ≤ 3×ULN OR ≤ 5×ULN for patients with liver metastases
• 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.
• Patients are expected to require any other form of systemic or localized antineoplastic therapy while on trial (including radiation therapy, and/or surgical resection).

Sponsors & Collaborators

• Samsung Medical Center: lead

Central Study Contacts

Sehoon Lee, MD, Phd

CONTACT

82-2-3410-6518; sehoon.lee119@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 24, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share