Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Maligna… (NCT07480733) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors
China480 participantsStarted 2026-04-23
Plain-language summary
This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 to 75 years, male or female.
✓. Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma.
✓. For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy; for melanoma: disease progression following prior chemotherapy and PD-(L)1 inhibitor therapy.
✓. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✓. Life expectancy ≥ 12 weeks.
✓. Adequate organ function.
✓. Male and female subjects of reproductive potential must agree to use highly effective contraception during the study and avoid conception; women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding.
Exclusion criteria
✕. Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.
✕. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v5.0 or to the level specified in the inclusion/exclusion criteria.
✕. Presence of active central nervous system (CNS) metastases.
✕. Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.
✕. Uncontrolled hypertension despite medical therapy, or history of hypertensive crisis or hypertensive encephalopathy.
✕. Severe cardiovascular or cerebrovascular disease.
✕. History of interstitial lung disease (ILD)/non-infectious pneumonitis requiring corticosteroid therapy.
✕. Severe bone injury due to tumor bone metastasis as judged by the investigator.