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QLC5508 vs Docetaxel in mCRPC
NCT07632690Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Primary completion
- Jun 2028
- Sponsor
- Qilu Pharmaceutical
- Drugs
- MHB088C
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
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Overview
Phase 3, randomised, open-label trial of MHB088C in metastatic castration-resistant prostate cancer (mCRPC) (2 arms), sponsored by Qilu Pharmaceutical. Primary endpoint: Radiographic Progression-Free Survival at 36 months. Planned start Jun 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
QLC5508 arm
QLC5508 2.0 mg/kg Q2W, administered as an IV infusion
Docetaxel arm
Docetaxel 75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)
03
Who it enrols
Adult males with mCRPC who have progressed after novel hormonal agents, with ECOG 0-1 and adequate organ function, excluding those with prior B7-H3 or TOP1i therapies.
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Endpoints
Primary
Radiographic Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
Prostate-specific Antigen Response Rate
Time to Prostate-specific Antigen Progression
Time to Pain Progression
Number of Participants Who Experienced at Least One Adverse Event
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