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

NCT07115446 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20093-107
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Keywords

Advanced prostate cancer; B7H3; HS-20093

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)

  Number of participants with dose limiting toxicity

  21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months

Secondary Outcomes (10)

• To evaluate the incidence and severity of adverse events (AEs)

  From the first dose(C1D1) up to 30 days after the last dose of HRS-5041 or 90 days after the last dose of HS-20093 (whichever is later)

• To evaluate the maximum plasma concentration (Cmax)

  up to approximately 24 months

• To evaluate the Time to reach maximum plasma concentration (Tmax)

  up to approximately 24 months

• To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC)

  up to approximately 24 months

• To evaluate the immunogenicity of HS-20093

  up to approximately 24 months

Study Arms (1)

HS-20093+HRS-5041

EXPERIMENTAL

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

Drug: HS-20093; Drug: HRS-5041

Interventions

HS-20093 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.

HS-20093+HRS-5041

HRS-5041 DRUG

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

HS-20093+HRS-5041

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)