QLF4113 in Participants With Metastatic Prostate Cancer

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07636707
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QLF4113 for injection — DRUG
    A PSMA/CD3/CD2 antibody

Study Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
Jul 20, 2026
Status verified
Jun 2026
Primary completion
Jan 5, 2028
Completion
Dec 5, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QLF4113 dose escalation arm

Primary Outcome Measure

Maximum tolerated dose (MTD) (Phase Ia) [ Time Frame: From first dose of study treatment until the end of Cycle 1 (21 days) ]

Central Contacts

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