Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Recruiting · NCT07115446 · Interventional (participants receive a specific treatment) · Lead sponsor: Hansoh BioMedical R&D Company
View the official record on ClinicalTrials.gov →Interventions studied
HRS-5041HS-20093
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, China