RecruitingPhase 1NCT07115446

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer

A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer


Sponsor

Hansoh BioMedical R&D Company

Enrollment

63 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors. This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two experimental cancer drugs — HS-20093 (an antibody-drug conjugate targeting B7-H3) and HRS-5041 (a targeted hormone therapy) — in men with advanced prostate cancer that has spread and stopped responding to standard hormone treatments. **You may be eligible if...** - You are a man 18 or older - You have metastatic castration-resistant prostate cancer (mCRPC) — meaning it has spread and is no longer responding to hormone therapy - Your cancer progressed after at least one standard novel hormonal treatment (such as enzalutamide or abiraterone) - You are reasonably well and functional (ECOG score 0–1) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have previously received B7-H3 targeted therapy or AR PROTAC treatment - You have brain metastases - You have had other cancers - You have uncontrolled heart disease, active infections, or severe lung disease - You have significant unresolved side effects from prior treatment 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

DRUGHS-20093

Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

DRUGHRS-5041

HRS-5041 was given oral administration, QD, at a 21-day cycle.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07115446


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