drugset / Trial / NCT07636707

QLF4113 in Participants With Metastatic Prostate Cancer

NCT07636707 ↗

Phase 1 Not yet recruiting 140 enrolled Qilu Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-07-20
Primary completion
2028-01-05
Completion
2028-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject QLF4113 Unknown — —

Indications