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New shot aims to reverse cancer wasting

NCT ID NCT07519564

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 called GB18 in 18-36 cancer patients who are losing weight and appetite due to their illness (cachexia). The drug is given as a shot under the skin. The main goal is to check safety, but researchers will also see if it helps patients gain weight and muscle.

What this could mean

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

Active substance
GB18 (a monoclonal antibody)
What this could lead to
If it works, this could lead to a treatment that helps cancer patients with cachexia regain appetite and weight, improving their quality of life.
What could go wrong
This is a very early Phase 1 trial with only 18-36 people, so it's too soon to know if it works. The main goal is safety, not effectiveness.

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 18 people

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

Started

Jun 2026

Expected to finish

Dec 2027

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.

Key Inclusion Criteria: * Voluntarily serve as a participant and sign the informed consent form; * Age ≥ 18 years; * Histologically or cytologically confirmed, non-resectable, locally advanced, recurrent, or metastatic solid tumors with failed standard treatment or have no standard treatment options. This includes, but is not limited to, colorectal cancer, pancreatic cancer, gastric cancer, esophageal cancer, biliary tract cancer, non-small cell lung cancer, prostate cancer, breast cancer, or ovarian cancer. * Diagnosed with cancer cachexia: BMI \< 18.5 kg/m², and no unintentional weight loss \> 2% within 6 months before screening, or no unintentional weight loss \> 5% within 6 months before screening regardless of BMI. * A serum GDF15 concentration ≥ 1.5 ng/mL. * Laboratory Test Requirements: 1. Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 80 g/L. 2. Serum creatinine ≤ 1.5 × ULN (Upper Limit of Normal). 3. Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN for patients with liver metastasis). 4. Activated partial thromboplastin time ≤ 1.5 × ULN, International Normalized Ratio ≤ 1.5. 5. Left Ventricular Ejection Fraction \> 50% as assessed by echocardiogram. * Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2 points * Expected survival period ≥ 4 months. Key Exclusion Criteria: * Known active/symptomatic central nervous system metastases and/or carcinomatous meningitis. * Plan to receive radiotherapy as a component of the primary antitumor treatment regimen. * BMI \> 26 kg/m². * Presence of reversible causes for reduced food intake, including but not limited to NCI CTCAE grade 3 or 4 oral mucositis; NCI CTCAE grade 3 or 4 nausea, vomiting, diarrhea, or constipation; mechanical obstruction preventing oral intake. * Comorbid conditions unrelated to tumor cachexia that cause difficulty in eating or malabsorption. * Cachexia due to other investigator-determined or clearly defined causes. History within the past 6 months of any of the following: myocardial infarction, congenital long QT syndrome, second- or third-degree atrioventricular block, arrhythmias (including sustained ventricular tachycardia or ventricular fibrillation), unstable angina, acute coronary syndrome, symptomatic congestive heart failure (NYHA class III or IV) of coronary or peripheral origin, stroke, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant thromboembolic disease. * Hypertension with unsatisfactory control despite antihypertensive therapy (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg). * Patients receiving tube feeding or parenteral nutrition (total or partial) within 28 days before the first administration of the investigational drug. * Initiation of new systemic glucocorticoid therapy from 28 days before the first dose of the investigational drug to the end of the study. * Major surgery not yet recovered from within 28 days before the first dose of the investigational drug (central venous access placement and tumor biopsy are not considered major surgery), or anticipated major surgery during the study period. * Prior participation in clinical trials targeting the GDF-15/GFRAL signaling pathways, or receipt of other investigational agents within 28 days or five half-lives (whichever is shorter) before the first dose of the investigational drug. * Severe infection requiring intravenous antibiotics, antivirals, or antifungal agents within 14 days before the first dose of the investigational drug.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102200, China

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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