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.
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 or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and/or PD-(L)1 inhibitor therapy.
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
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 v6.0 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.