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New hope for Hard-to-Treat cancers: experimental drug QLS1317 enters human trials

NCT ID NCT07552376

Disease control Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new drug called QLS1317 in 120 people with advanced solid tumors that have high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR). These patients have already tried standard treatments without success. The study aims to find a safe dose and see if the drug can shrink tumors.

What this could mean

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

Active substance
QLS1317
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have specific genetic features (MSI-H/dMMR) and have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial with only 120 participants, so it is primarily testing safety and dosing. The drug may not prove effective, and side effects are unknown at this stage.

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 120 people

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

Expected to start

May 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

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. Males or females aged ≥ 18 at the time of signing the informed consent form (ICF). 2\. Expected survival duration ≥ 3 months. 3. Participants with advanced solid tumors of MSI-H/dMMR who have failed standard treatment. 4\. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-1. 6\. Patients with sufficient organ function. Exclusion Criteria: * 1\. Have a history of allergy to any component of the study drug. 2. Oral medication is not allowed. 3. The residual toxic reactions caused by previous anti-tumor treatment are higher than Grade 1 according to CTCAE v6.0. 4\. Known or discovered during screening period to have active central nervous system metastasis. 5\. Having suffered from other malignant tumors within 5 years prior to the first dose. 6\. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage or treatment. 7\. Chronic active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. 8\. Suffering from severe cardiovascular and cerebrovascular diseases. 9. Any severe or uncontrollable systemic disease. 10. Have received allogeneic tissue/solid organ transplantation.

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As listed by the trial registrant

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

Msi-H or DMMR advanced solid tumors

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.

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