HS-20093 plus HRS-5041 for 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
This phase Ib trial will test whether combining HS-20093, a B7-H3–targeted antibody-drug conjugate, with HRS-5041, an androgen receptor–targeting PROTAC, is safe and tolerable in men with metastatic castration-resistant prostate cancer who have progressed on prior hormonal therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07115446 on ClinicalTrials.gov |
What this trial studies
This open-label, phase Ib multicenter study administers escalating doses of HS-20093 in combination with HRS-5041 to define safety, tolerability, and pharmacokinetics. HS-20093 is a fully human IgG1 antibody-drug conjugate directed at B7-H3, while HRS-5041 is a PROTAC designed to degrade the androgen receptor. Eligible participants are men with metastatic castration-resistant prostate cancer who progressed after at least one novel hormonal therapy, have ECOG performance status 0–1, and an estimated life expectancy of at least 12 weeks. Key exclusions include prior B7-H3 targeted therapy or AR PROTAC exposure, recent cytotoxic or investigational agents within 21 days, brain metastases, and unresolved toxicities greater than Grade 2.
Who should consider this trial
Good fit: Men aged 18 or older with metastatic castration-resistant prostate cancer who have progressed after at least one novel hormonal therapy, have ECOG 0–1, life expectancy ≥12 weeks, and agree to required contraception are the intended candidates.
Not a fit: Patients with prior B7-H3 targeted therapy or AR PROTAC treatment, brain metastases, recent cytotoxic/investigational anticancer therapy within 21 days, or unresolved toxicities > Grade 2 are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination could offer a new targeted option for men with hormone-resistant advanced prostate cancer that may overcome mechanisms of resistance.
How similar studies have performed: Early-phase studies of B7-H3-directed ADCs and AR-targeting degraders have shown encouraging signals, but the specific combination of these two approaches is novel and untested clinically.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.