drugset / Trial / NCT07636707
QLF4113 in Participants With Metastatic Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QLF4113 | Unknown | — | — |