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New drug QLF4113 enters first human tests for tough prostate cancer

NCT ID NCT07636707

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug, QLF4113, in about 140 men with metastatic castration-resistant prostate cancer that has spread and no longer responds to standard hormone therapy. The main goals are to find a safe dose and check for side effects, while also looking for signs that the drug shrinks tumors or lowers PSA levels. The study is not yet recruiting and is run by Qilu Pharmaceutical.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.