Actively Recruiting
Toripalimab（JS001） as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors
Led by Sun Yat-sen University · Updated on 2026-04-23
35
Participants Needed
4
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the response of toripalimab (JS001), a PD1 antibody, in participants with POLE or POLD-mutated and non microsatellite instability (non-MSI-H) advanced solid cancers.
CONDITIONS
Official Title
Toripalimab（JS001） as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent to participate
- Aged between 18 and 75 years old
- Have histologically or cytologically confirmed advanced solid tumors not responding to standard therapy
- Have MSS (microsatellite stability), MSI-L (microsatellite instability-low), or pMMR status
- Have germline or somatic mutations in POLE or POLD (excluding synonymous mutations)
- Refuse conventional chemotherapy or targeted therapy
- Willing to provide tumor biopsy and blood samples before and during treatment
- Have at least one measurable disease site per RECIST criteria
- ECOG performance status of 0 or 1
- Estimated life expectancy greater than 3 months
- Can provide more than 10 paraffin sections of tumor tissue
- No radiotherapy or non-targeted radiotherapy outside target lesions within 4 weeks before first treatment dose
- AST and ALT ≤ 2.5 times upper limit of normal (up to 5 times if liver metastasis present)
- Albumin ≥ 3 g/dL
- Alkaline phosphatase ≤ 2.5 times upper limit of normal
- Serum bilirubin < 1.5 mg/dL
- Creatinine ≤ upper limit of normal
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 90 g/L
- For females of childbearing potential, negative pregnancy test within 21 days before first dose
- Agreement to use contraception during treatment and for 28 days after last dose
You will not qualify if you...
- Confirmed or suspected brain metastases
- Cancerous meningitis
- No germline or somatic mutations in POLE or POLD
- MSI-H (microsatellite instability-high) or dMMR status
- Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors or other T cell checkpoint inhibitors
- Received cytotoxic, biologic, immunotherapy, or investigational drugs within 4 weeks before first dose
- Significant immunodeficiency or autoimmune conditions requiring treatment
- Systemic corticosteroid or immunosuppressive therapy exceeding 10 mg prednisolone daily
- Active tuberculosis or treatment for tuberculosis within 1 year
- Received anti-infection vaccines within 4 weeks before first dose
- Symptomatic heart failure, coronary heart disease, or recent myocardial infarction within 6 months
- Allergy to JS001 or its ingredients
- Pregnant or breastfeeding females
- Other active malignancies within 5 years except non-melanoma skin cancer
- Lack of legal capacity
- Positive tests for HIV/AIDS, hepatitis B or C
- Any medical condition that may affect study compliance or consent signing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
3
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
Research Team
F
Feng Wang, MD, PhD
CONTACT
Y
YING JIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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