QLF4113 in Participants With Metastatic Prostate Cancer

Phase 1Not Yet RecruitingNCT07636707

Qilu Pharmaceutical Co., Ltd.140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD) (Phase Ia)

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).

Time frame: From first dose of study treatment until the end of Cycle 1 (21 days)

Maximum administered dose (MAD)(Phase Ia)

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.

Time frame: From first dose of study treatment until the end of Cycle 1 (21 days)

recommended phase II dose (RP2D)

The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ia study.

Time frame: Through phase Ia completion, approximately 1 year.

The incidence and severity of adverse events (AE) (Phase Ib)

Incidence and severity of adverse events (AEs) evaluated according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCA) Version 6.0 (v6.0) and American Society for Transplantation and Cellular Therapy (ASTCT)

Time frame: Through phase Ia completion, approximately 1 year.

PSA50 response (Phase Ib)

Best response until progression, as defined by Response Evaluation Criteria in Solid Tumors （RECIST） version (v1.1) and Prostate Cancer Clinical Trials Working Group 3 (PCGW3).

Time frame: From Screening to confirmed progressive disease (approximately 1 year)

Objective response rate (ORR) (phase Ib)