Clinical trial · Interventional
QLF4113 in Participants With Metastatic Prostate Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLF4113 for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLF4113 dose escalation arm
- interventionNames
- Drug: QLF4113 for injection
Primary outcomes (6)
- measure
- Maximum tolerated dose (MTD) (Phase Ia)
- timeFrame
- From first dose of study treatment until the end of Cycle 1 (21 days)
- description
- Maximum tolerated dose is defined as the previous dose level at which 2 or more out of 2-6 participants experienced a dose-limited toxicity (DLT).
- measure
- Maximum administered dose (MAD)(Phase Ia)
- timeFrame
- From first dose of study treatment until the end of Cycle 1 (21 days)
- description
- MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features. * Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC). * Failed or are intolerant to standard therapies * Adequate function of major organs as defined by the protocol. * Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy). * Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments Exclusion Criteria: * Previously treated with drugs targeting CD3 or CD2. * Significant Cardiovascular Diseases * Active, Uncontrolled Infections * Immunosuppressive Treatment before the first dose of the investigational drug * Clinically Uncontrolled Third-Space Fluid Accumulation * History of Other Malignancies within 5 years prior to the first dose of the investigational drug * Moderate to Severe Pulmonary Diseases significantly affecting lung function, * Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse. * Allergy to the Investigational Drug or its Components. * Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.
References
Publications (0)
Data not yet available