Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
Phase II Study of the Combination of Sacituzumab Tirumotecan(SKB264)and Tagitanlimab (KL-A167) in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
Sponsor: Tianjin Medical University Second Hospital + Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Secondary Endpoints
Progression Free Survival(PFS)
Duration of Response(DOR)
Disease Control Rate (DCR)
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 …
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