QLF4113 in Participants With Metastatic Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Participants voluntarily agree to participate and sign the informed consent form.
Male, aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Life expectancy ≥ 3 months.
Disqualifiers
Previously treated with drugs targeting CD3 or CD2.
Significant Cardiovascular Diseases
Active, Uncontrolled Infections
Immunosuppressive Treatment before the first dose of the investigational drug
Trial design
Treatments tested in this trial
- QLF4113 for injection
Treatment groups
140 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov