Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
Trial Parameters
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 Commo