QLC5508 in Participants With Metastatic Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
Male, aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 3 months.
Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features.
Disqualifiers
1. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent.
Trial design
Treatments tested in this trial
- QLC5508
- Docetaxel
Treatment groups
700 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov