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

Hansoh Pharma

Status and phase

Enrolling

Phase 1

Conditions

Advanced Prostate Cancer

Treatments

Drug: HRS-5041

Drug: HS-20093

Study type

Interventional

Funder types

Industry

Identifiers

NCT07115446

HS-20093-107

Details and patient eligibility

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.

Enrollment

63 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.