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New drug combo targets advanced cancers in early trial

NCT ID NCT07453394

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests an experimental drug called QLS5132, given with other cancer treatments, for people with advanced solid tumors like stomach, lung, endometrial, and ovarian cancers. The goal is to find safe doses and see if the combination shrinks tumors. About 626 participants will receive the drug and be monitored for side effects and treatment response.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 626 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

Anyone

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: 1. Advanced solid tumors; 2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1); 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Adequate organ function; 5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral. Exclusion Criteria: 1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \[ADCs\]), or any drug containing topoisomerase I inhibitors (including ADCs); 2. Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132; 3. Progressive or symptomatic brain metastases; 4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection; 5. History of significant cardiac disease, or poorly controlled diabetes mellitus; 6. History of recurrent autoimmune diseases; 7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML); 8. History of a second primary malignancy; 9. If female, is pregnant or breastfeeding; 10. Be allergic to any component of QLS5132 or its excipients.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm gastric cancer gastric neoplasm neoplasm non-small cell lung carcinoma ovarian cancer

As listed by the trial registrant

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

Advanced solid tumors Endometrial cancer Gastric cancer (GC) Non-small cell lung cancer (NSCLC) Ovarian 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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