Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
Trial Parameters
Brief Summary
This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and Tagitanlimab (KL-A167) in the treatment of AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer).
Eligibility Criteria
Inclusion Criteria: 1. Age at the time of signing the informed consent form is ≥ 18 years old; 2. AVPC or NEPC diagnosed based on recent histological and/or clinical criteria; 3. Having received one or two second-generation anti androgen therapies in the past, previous use of docetaxel for castration resistant prostate cancer (CRPC) is allowed, and the use of other chemotherapy is not allowed; 4. The progression of prostate cancer in the subjects within 6 months prior to screening shall be determined by the researcher through one of the following methods: PSA is evaluated by local laboratories, and PSA progression is defined as at least two increases in PSA levels at intervals of ≥ 1 week, with a screening PSA value of ≥ 2 ng/ml. • Soft tissue imaging disease progression determined based on PCWG modified RECIST 1.1 or RECIST 1.1 criteria, regardless of PSA progression. The imaging disease progression of bones is defined as the appearance of two or more new bone lesions in bone scans, r