Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07179783 | Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC) | PHASE2 | RECRUITING | 28 | — | — | Sep 22, 2025 | Jul 31, 2027 | Sep 18, 2025 | 1 | China |
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1)/ Prostate Cancer Clinical Trials Working Group(PCWG3).
| Arm | Type | Description |
|---|---|---|
| SKB264-KL-A167 Treatment Group | EXPERIMENTAL | This treatment group will receive a combination therapy of SKB264 and KL-A167. |
| Name | Type | Description |
|---|---|---|
| Sacituzumab Tirumotecan | DRUG | Drug reduction will be implemented according to the research plan. |
| Tagitanlimab | DRUG | Treatment with Sacituzumab Tirumotecan (SKB264, 5mg/kg IV d1 Q2W) and Tagitanlimab (KL-A167 , 900mg IV d1 Q2W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient), with a maximum treatment duration of 24 months for Tagitanlimab. Drug reduction will be implemented according to the research plan. |
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 castrati...