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New drug QLC5508 takes on chemo in prostate cancer battle

NCT ID NCT07632690

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial compares an experimental drug, QLC5508, against the standard chemotherapy docetaxel in 700 men with metastatic castration-resistant prostate cancer that has worsened after hormone therapy. The main goal is to see if QLC5508 delays cancer growth better than docetaxel. Participants will receive either QLC5508 or docetaxel, and the study will track how long the cancer stays under control and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QLC5508 (an experimental drug) and docetaxel (a standard chemotherapy)
What this could lead to
If QLC5508 works better than docetaxel, it could offer a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. QLC5508 may not prove more effective or safer than docetaxel, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

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: * Male, aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 3 months. * Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features. * Diagnosis of metastatic castration-resistant prostate cancer (mCRPC). * Prior treatment with novel hormonal agents (NHAs) and documented disease progression. * Adequate organ function. * Recovery from all reversible adverse events (AEs) related to prior anticancer therapies. Exclusion Criteria: * 1\. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent. 2\. History of or current significant cardiovascular or cerebrovascular disease. 3. Active, uncontrolled infection. 4. Concurrent or prior history of another primary malignancy 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis, or current ILD/non-infectious pneumonitis 6. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh class B or worse. 7\. Known hypersensitivity or allergy to any investigational product or its excipients.

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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

Only the study team decides who joins. These are the ways to reach them.

  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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