Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Prostate Cancer (Adenocarcinoma)Prostate Cancer Metastatic Castration-ResistantProstate Adenocarcinoma With Neuroendocrine Differentiation
Interventions
DRUG

Sacituzumab Tirumotecan

Drug reduction will be implemented according to the research plan.

DRUG

Tagitanlimab

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.

Trial Locations (1)

300211

RECRUITING

Tianjin Medical Unversity Second Hospital, Tianjin

All Listed Sponsors
collaborator

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

lead

Tianjin Medical University Second Hospital

OTHER

NCT07179783 - Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC) | Biotech Hunter | Biotech Hunter