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

NCT07115446 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

HRS-5041

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

Sponsors & Collaborators

  • Hansoh BioMedical R&D Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115446 on ClinicalTrials.gov