Can a new injection stop the wasting of cancer cachexia?

NCT ID NCT07735104

Symptom relief Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called QLS2319 for cancer cachexia — the severe weight loss and muscle wasting that can happen with advanced cancer. The study first gives a single dose to healthy volunteers to check safety, then gives multiple doses to people with cancer cachexia to see if it is safe and might help. The goal is to gather initial information on whether this approach is worth studying further.

What this could mean

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

Active substance: an experimental drug called QLS2319, given as a shot under the skin
What this could lead to: If it works, this could point toward a treatment for the severe weight loss and muscle wasting that often accompanies advanced cancer.
What could go wrong: This is an early-phase trial, so the drug may not prove safe or effective. Side effects are unknown, and results in healthy volunteers may not predict outcomes in cancer patients.

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 88 people

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

Expected to start

Sep 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 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Ia phase: 1. Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.; 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive); 3. Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose; Ib phase: 1. Subjects aged ≥ 18 years at screening; 2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 3. ECOG performance status score of 0, 1; 4. Cancer cachexia documented in medical records; - Exclusion Criteria: Ia phase: 1. Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study. 2. History of HIV infection, syphilis, hepatitis B, or hepatitis C; 3. History of recurrent infections or active infections； 4. Subjects who, in the judgment of the investigator, are not suitable for participation in the study. Ib phase: 1. Current active reversible causes of decreased food intake 2. Cachexia caused by other reasons 3. Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product 4. Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food. 5. Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.

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Conditions

The condition(s) this trial relates to.

paraneoplastic syndrome

As listed by the trial registrant

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

Cancer cachexia Cancer cachexia syndrome

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

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

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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.

Can a new injection stop the wasting of cancer cachexia?

What the study statuses mean