Actively Recruiting
Phase Ib Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HS-20093 Combined With HRS-5041 in Advanced Prostate Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2025-12-05
63
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of HS-20093, a humanized antibody-drug conjugate targeting B7-H3 on solid tumor cells, and HRS-5041, a PROTAC that targets androgen receptors, in patients with advanced prostate cancer who have progressed after hormonal therapy. This phase Ib, open-label, multi-center study focuses on assessing the safety, tolerability, and how the body processes these drugs in this patient group. Participants will receive HS-20093 intravenously every three weeks at the recommended phase 2 dose and HRS-5041 orally once daily in 21-day cycles. Treatment continues until unacceptable side effects or confirmed disease progression occur. The study includes dose escalation to find the maximum tolerated or administered dose within 21 days after the first dose. During the study, participants will be closely monitored for side effects and drug levels up to 24 months. Researchers will evaluate tumor response using specific criteria, prostate-specific antigen levels, and duration of response. Safety assessments include adverse event tracking up to 30 or 90 days after treatment ends, depending on the drug. Participants' overall health and organ functions will be regularly checked throughout the study.
CONDITIONS
Brief Title
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Voluntary participation with signed informed consent
- Diagnosis of metastatic castration-resistant prostate cancer progressing after at least one novel hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Estimated life expectancy of at least 12 weeks
- Use of adequate contraception during the study and for 3 months after last dose of HRS-5041 or 4.5 months after last dose of HS-20093, whichever is later
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Previous treatment with androgen receptor PROTAC therapy
- Cytotoxic chemotherapy, investigational agents, or anticancer drugs within 21 days before starting study treatment
- Presence of brain metastases
- Unresolved toxicities greater than Grade 2 from prior therapy
- History of other primary cancers
- Inadequate bone marrow or organ function
- Severe, uncontrolled cardiovascular disease
- Severe or uncontrolled diabetes
- Active infectious diseases
- Known or suspected interstitial lung disease
- History of serious neuropathy or mental disorders
- History of severe hypersensitivity or infusion reactions
- Allergies to any ingredients in HS-20093
- Inability to comply with study procedures
- Any condition that could affect safety or study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive intravenous HS-20093 every 3 weeks and oral HRS-5041 daily in 21-day cycles. Treatment continues until unacceptable toxicities or confirmed disease progression.
Regular visits for treatment and monitoring as per protocol
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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