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QLF4113 in Participants With Metastatic Prostate Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer. The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.
Official title: An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-07-20
Completion Date
2028-12-05
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
QLF4113 for injection
A PSMA/CD3/CD2 antibody