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

NCT ID: NCT07115446

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-19
• Study Completion Date: 2028-12-31

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.

Conditions

Advanced Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HS-20093+HRS-5041

Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2.

Group Type: EXPERIMENTAL

HS-20093

Intervention Type: DRUG

Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

HRS-5041

Intervention Type: DRUG

HRS-5041 was given oral administration, QD, at a 21-day cycle.

Interventions

HS-20093

Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Intervention Type: DRUG

HRS-5041

HRS-5041 was given oral administration, QD, at a 21-day cycle.

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hansoh BioMedical R&D Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Fudan University Shanghai Cancer Center

Role: primary

021-34778299

Other Identifiers

HS-20093-107

Identifier Type: -

Identifier Source: org_study_id