Not Yet RecruitingPhase 2

A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy

China31 participantsStarted 2025-10-30

Plain-language summary

This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive JS004（B/T lymphocyte attenuator factor monoclonal antibody） plus Toripalimab until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators(continuous treatment for up to 2 years).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Have fully understood and voluntarily signed the Informed Consent Form (ICF);
✓. 18-75 years old (at the time of signing the informed consent form); No gender restrictions; ECOG PS score: 0-1 points;
✓. Renal cell carcinoma with clear cell components confirmed by histology or cell pathology, including metastatic renal cell carcinoma mainly composed of clear cell components;
✓. Previous treatment history of the subject: Patients who have received 1-2 systemic treatments containing immunotherapy and have experienced disease progression or intolerance;
✓. Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
✓. Agree to provide sufficient previously stored tumor tissue specimens or agree to undergo biopsy
✓. Blood routine examination standards (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 2 weeks before the first trial medication):
✓. Hemoglobin (HGB) ≥ 90g/L;

Exclusion criteria

What they're measuring

ORR per RECIST v1.1 as assessed by investigators

Timeframe: Up to 2 years

Trial details

NCT IDNCT06730932

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Jiwei Huang, Dr

021-68383544 jiweihuang@outlook.com

View on ClinicalTrials.gov More Unresectable or Advanced Clear Cell Renal Cell Carcinoma That Has Progressed After Previous Immunotherapy trials