Refractory Solid Cancer Patients Unexposed to ImmunotherapyPhase 2NCT07300891
T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherapy) for Refractory Solid Cancer Patients Unexposed to Immunotherapy
A Phase 2 study testing Tisleizumab(BGB-A317) in people with Refractory Solid Cancer Patients Unexposed to Immunotherapy, run by Samsung Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Refractory Solid Cancer Patients Unexposed to Immunotherapy
- What is being tested?
- Tisleizumab(BGB-A317)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 31 Jan 2028
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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
- Key exclusion criteria Patients who meet any of the following criteria at the time of assessment will be excluded.
- 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).
- Patients who have previously received treatment with PD-1/PD-L1 inhibitor or CTLA-4 inhibitor e.g. pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, durvalumab, tislelizumab, dostarlimab, spartalizumab tremelimumab or ipilimumab
- Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before first dose of study drug.
- Patients have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study in terms of efficacy and safety, interfere with the subject's participation for the full duration of the trial, or are not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Women who are pregnant or breastfeeding, or possibly pregnant.
- Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before first dose of study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- Tisleizumab(BGB-A317)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisleizumab(BGB-A317)Drug
T cell inflamed GEP score
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab(BGB-A317) | Experimental | Not described Receives: Drug: Tisleizumab(BGB-A317) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
- OS is defined as the time from first dose of study drug until death from any cause.
Measured: 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.
PFS is defined as the time from first dose
Measured: 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.
CBR is defined as the proportion of patients with best overall response of CR and PR, or at least six months of stable disease, per RECIST v1.1.
Measured: From enrollment to the end of treatment at 30days(+/-7)
DOR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857treated with Tislelizumab.
DOR is defined as the time from the first determination of an objective response per RECIST v1.1, until objective tumor progression or death from any cause, whichever occurs first.
Measured: From enrollment to the end of treatment at 30days(+/-7)
iORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
iORR is defined as the proportion of patients who had CR or PR assessed by investigator using iRECIST
Measured: From enrollment to the end of treatment at 30days(+/-7)
iPFS in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
iPFS is defined as the time from first dose of study drug until objective tumor progression per iRECIST or death from any cause, whichever occurs first.
Measured: From enrollment to the end of treatment at 30days(+/-7)
iCBR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
iCBR is defined as the proportion of patients with best overall response of CR and PR, or at least six months of stable disease, per iRECIST.
Measured: From enrollment to the end of treatment at 30days(+/-7)
iDOR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
iDOR is defined as the time from the first determination of an objective response per iRECIST, until objective tumor progression or death from any cause, whichever occurs first.
Measured: From enrollment to the end of treatment at 30days(+/-7)
The safety of Tislelizumab in refractory solid tumor patients per NCI CTCAE v5.0
Measured: From enrollment to the end of treatment at 30days(+/-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startAug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid Cancer Patients Unexposed to ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300891
- Sponsor's protocol ID
- PAN-IO-001
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. However, study results and summary data will be made available through the ClinicalTrials.gov results module and/or peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherapy) for Refractory Solid Cancer Patients Unexposed to Immunotherapy
- ClinicalTrials.gov ID
- NCT07300891
- Acronym / sponsor ID
- PAN-IO-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 Dec 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab(BGB-A317) | Experimental | Drug: Tisleizumab(BGB-A317) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Tisleizumab(BGB-A317)T cell inflamed GEP score | Drug | Tislelizumab(BGB-A317) |
Primary outcome
ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab
Time frame: From enrollment to the end of treatment at 30days(+/-7)
ORR is defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by investigator using RECIST v1.1
11 secondary outcomes
ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.955 treated with Tislelizumab.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
DOR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857treated with Tislelizumab.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
iORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
iPFS in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
iCBR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
iDOR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab.
Time frame: From enrollment to the end of treatment at 30days(+/-7)
The safety of Tislelizumab in refractory solid tumor patients per NCI CTCAE v5.0
Time frame: From enrollment to the end of treatment at 30days(+/-7)
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 28 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. However, study results and summary data will be made available through the ClinicalTrials.gov results module and/or peer-reviewed publications.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tisleizumab(BGB-A317) in people with Refractory Solid Cancer Patients Unexposed to Immunotherapy, run by Samsung Medical Center.
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 12 inclusion and 21 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sehoon Lee, MD, Phd (82-2-3410-6518, sehoon.lee119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR in refractory solid tumor patients with T cell inflamed GEP score ≥ 0.857 treated with Tislelizumab (time frame: From enrollment to the end of treatment at 30days(+/-7)). 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 28 Apr 2026.