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.

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 Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: QLF4113 for injection

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jun Guo, Doctor; Phone Number: 0086-10- 88121122; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLF4113 dose escalation arm	Drug: QLF4113 for injection; A PSMA/CD3/CD2 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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)	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).	From Screening to confirmed progressive disease (approximately 1 year)
Objective response rate (ORR) (phase Ib)		From Screening to confirmed progressive disease (approximately 1 year)

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): December 5, 2028

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: QLF4113-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No