Tests two new drugs together in men with advanced prostate cancer
Tests HS-20093 and HRS-5041 together in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hansoh BioMedical R&D Company
- Trial code
- NCT07115446
- Record updated
- 5 December 2025
- Original description
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.Read full original descriptionShow less
A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
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.
Inclusion: Men greater than or equal to 18 years; Voluntarily to participate, Signed and dated Informed Consent Form; Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment); Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1; Estimated life expectancy ≥ 12 weeks; Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).
Exclusion: Treatment with any of the following:; Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases; Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0; History of other primary malignancies; Severe, uncontrolled or active cardiovascular diseases; Severe or uncontrolled diabetes; The presence of active infectious diseases; Any known or suspected interstitial lung disease; History of serious neuropathy or mental disorders; History of severe hypersensitivity reaction, severe infusion reaction; Hypersensitivity to any ingredient of HS-20093; Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments; Inadequate bone marrow reserve or organ dysfunction; Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.