A Study of QLS2401 Injection in Participants With Advanced Prostate Cancer

StatusNot Yet Recruiting
PhasePhase 1
Started

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Record History

  1. Study First Submitted
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy in patients with advanced prostate cancer. The Phase I trial is divided into Phase Ia and Phase Ib components. The Phase Ia component involves a dose-escalation study of QLS2401 as monotherapy; should the results from the Phase Ia study meet the predefined criteria, a Phase Ib efficacy-expansion study of QLS2401 as monotherapy will be conducted.
Trial Details
NCT Number NCT07869888
Lead Sponsor Shanghai Qilu Pharmaceutical Research and Development Center LTD
Conditions
(from sponsor)		 Advanced Prostate Cancer
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov