Trials / Recruiting
RecruitingNCT07115446
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- Sponsor
- Hansoh BioMedical R&D Company · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-08-19
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-08-11
- Last updated
- 2025-12-05
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07115446. Inclusion in this directory is not an endorsement.