Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
HS-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.
HRS-5041: HRS-5041 was given oral administration, QD, at a 21-day cycle.
Study 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
Primary outcome measure(s)
- To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD) — 21 days from administration of the first dose (C1D1) in the dose escalation phase, assessed up to 24 months
Number of participants with dose limiting toxicity
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07115446 on ClinicalTrials.gov ↗ ← All trials in China