NCT07115446 Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
| NCT ID | NCT07115446 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 63 participants in total. It began in 2025-08-19 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Treatment with any of the following: a. 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. * Inadequate bone marrow reserve or organ dysfunction. * 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. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator. * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Frequently Asked Questions
Who can join the NCT07115446 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07115446 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07115446 currently recruiting?
Yes, NCT07115446 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hansoh BioMedical R&D Company to inquire about joining.
Where is the NCT07115446 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07115446 clinical trial?
NCT07115446 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 63 participants.
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