QLC5508
Drug2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
NCT Number: NCT07632690
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).
Trial opening soon.
Get Notified18 year and older
Male
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Time frame: Up to approximately 36 months
Contact information is provided by the study sponsor or research team.
Qilu Pharmaceutical Co., Ltd.
Industry
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).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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