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NOT YET RECRUITING
NCT07632690
PHASE3

QLC5508 in Participants With Metastatic Prostate Cancer

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, active-controlled, multicenter Phase III trial evaluating QLC5508 versus docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior treatment with novel hormonal agents (NHAs). Participants are randomized to receive either QLC5508 monotherapy (experimental arm) or docetaxel (control arm). The primary objective is to compare the efficacy of QLC5508 versus docetaxel, as measured by radiographic progression-free survival (rPFS) assessed by an Independent Radiological Review Committee (IRC).

Official title: A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial Comparing QLC5508 Versus Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Progressed After Treatment With Novel Hormonal Agents (NHA).

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2026-06-20

Completion Date

2030-11-20

Last Updated

2026-06-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

QLC5508

2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

DRUG

Docetaxel

75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)