RecruitingPhase 2NCT07179783

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

Enrollment

28 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — sacituzumab tirumotecan plus tagitanlimab — in men with an aggressive, hard-to-treat form of prostate cancer called aggressive variant prostate cancer (AVPC) or neuroendocrine prostate cancer (NEPC) that has stopped responding to hormone-blocking therapies. **You may be eligible if...** - You are 18 or older - You have been diagnosed with aggressive variant or neuroendocrine prostate cancer - You have already tried one or two second-generation hormone therapies (like enzalutamide or abiraterone) - Your cancer has shown signs of getting worse in the past 6 months based on PSA levels or imaging **You may NOT be eligible if...** - You have had more than two prior lines of chemotherapy for prostate cancer (beyond docetaxel) - You have active, uncontrolled infections or serious organ problems - You have active brain metastases - You are on certain blood-thinning medications with uncontrolled clotting issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Tirumotecan

Drug reduction will be implemented according to the research plan.

DRUGTagitanlimab

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.


Locations(1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

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NCT07179783


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