NCT07179783

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

More than 60% of newly diagnosed cases of prostate cancer in China are in the middle and late stages, with an overall poor prognosis. Prostate cancer is AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer), two highly invasive and poorly prognosis non androgen receptor driven subtypes of prostate cancer. The overall prognosis of advanced AVPC and NEPC is poor, with a median OS of only 7-20 months after diagnosis. At present, there is a lack of a unified standard protocol for drug treatment of AVPC and NEPC. The recommended treatment plan in the diagnosis and treatment guidelines is mainly platinum based chemotherapy, as the behavior of AVPC and NEPC is similar to that of small cell lung cancer, and can be treated according to the guidelines for small cell lung cancer.More research is still underway on the use of immunotherapy combined with chemotherapy for advanced AVPC/NEPC. 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 advanced AVPC and NEPC.The above research suggests that immunotherapy combined with chemotherapy has further exploration value in advanced AVPC/NEPC.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Prostate Cancer Metastatic Castration-Resistant
• Prostate Adenocarcinoma With Neuroendocrine Differentiation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2027-06-30
• Completion: 2027-07-31
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: China