drugset / Trial / NCT07632690

QLC5508 in Participants With Metastatic Prostate Cancer

NCT07632690

Phase 3 Not yet recruiting 700 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-06-20
Primary completion
2028-06-20
Completion
2030-11-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject QLC5508 Other / unclassified 2 mg/kg Intravenous

Indications