Phase Ib Study of HS-20093+HRS-5041 in Patients With 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

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.

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.