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HRS-5041 Combined With Antitumor Therapy in Advanced Prostate Cancer
NCT06568094Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Hengrui
- Modality
- Bivalent/Multivalent Binders, PROTACs (E3 ligase recruitment)
- Drugs
- HRS-5041
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label trial of HRS-5041 in prostate cancer (PCa) (7 arms), sponsored by Hengrui. Primary endpoints: Recommended Phase II Dose at 28 days, Incidence and severity of adverse events at 2 years and 1 more. Started Sep 2024; status: recruiting.
02
Design
7 arms- Study design
- Open-label
HRS-5041 + Abiraterone + Prednisone
HRS-5041 tablets combined with Abiraterone Acetate tablets and Prednisone Acetate tablets
HRS-5041 + Docetaxel + Prednisone
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
HRS-5041 + HRS-1167
HRS-5041 tablets combined with HRS-1167 tablets
HRS-5041 + SHR2554
HRS-5041 tablets combined with SHR2554 tablets
HRS-5041 + HRS-6208
HRS-5041 tablets combined with HRS-6208 capsules
HRS-6208 + Abiraterone + Prednisone
HRS-6208 capsules combined with Abiraterone Acetate tablets and Prednisone Acetate tablets
1 more in the full profile.
03
Who it enrols
Male patients >= 18 years old with advanced prostate adenocarcinoma, ECOG 0-1, life expectancy >= 12 weeks, and adequate organ function. Excludes patients with neuroendocrine or small cell carcinoma, recent major surgery, active CNS metastases, severe cardiovascular disease, or active infections.
04
Endpoints
Primary
Recommended Phase II Dose
Incidence and severity of adverse events
Prostate-Specific Antigen response rate
Secondary
Objective Response Rate
Disease Control Rate
Duration of Response
Prostate-Specific Antigen response rate
Time to Prostate-Specific Antigen progression
Radiographic Progression-Free Survival
Overall Survival
Blood concentrations of study drugs
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