NCT07115446RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 19 Aug 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hansoh BioMedical R&D Company
- Diseases
- Prostate cancer
- NCT number
- NCT07115446
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 63
- From 19 Aug 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Inadequate bone marrow reserve or organ dysfunction.
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.