Actively Recruiting
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2025-12-05
63
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Male participants aged 18 years or older
- Voluntary participation with signed informed consent
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) that progressed after at least one type of novel hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Use of adequate contraceptive measures throughout the study and for a defined period after last dose of study drugs
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Previous treatment with androgen receptor PROTAC
- Use of cytotoxic chemotherapy, investigational agents, or anticancer drugs within 21 days before starting study treatment
- Presence of brain metastases
- Unresolved toxicities from prior therapy greater than Grade 2 according to CTCAE 5.0
- History of other primary cancers
- Inadequate bone marrow or organ function
- Severe, uncontrolled, or active 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
- Hypersensitivity to any ingredient of HS-20093
- Inability or unwillingness to comply with study procedures and restrictions
- Any condition that may compromise safety or study assessments in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here