QLF4113 in Participants With Metastatic Prostate Cancer

NCT07636707 | Not Yet Recruiting Phase 1

• 1 other identifier: QLF4113-101
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

QLF4113 dose escalation arm

EXPERIMENTAL

Drug: QLF4113 for injection

Interventions

QLF4113 for injection DRUG

A PSMA/CD3/CD2 antibody

QLF4113 dose escalation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jun Guo, Doctor

CONTACT

0086-10- 88121122; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): December 5, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share