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New combo therapy targets Hard-to-Treat cancers

NCT ID NCT07387081

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called LM-24C5 combined with other cancer treatments for people with advanced solid tumors that have a specific protein (CEACAM5). About 130 adults aged 18-80 whose cancer has returned or not responded to standard care will participate. The goal is to see if the combination can shrink tumors and control the disease.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

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

Started

Dec 2025

Expected to finish

Oct 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 80 years

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. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged 18-80 years old (including boundary values) , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy. 6. CEACAM5-positive subjects. 7. At least one evaluable lesion. 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose. 9. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: 1. Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix/breast, and other malignancies deemed by the investigator to potentially benefit from participation in this study. 2. Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5. 3. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 5. Present peripheral sensory or motor neuropathy ≥ grade 2. 6. Subjects with uncontrolled pain. 7. Subjects with symptomatic and untreated central nervous system metastases, and/or meningeal metastases. 8. Subjects who have uncontrollable third space effusion. 9. Previously received targeted therapy for same target. 10. . Use of any live vaccines within 28 days prior to 1st dosing of IMP. 11. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy. 12. Subjects on anticoagulants, such as heparin and vitamin K antagonists. 13. Clinically uncontrollable persistent recurrent vomiting. 14. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP. 15. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of IMP. 16. Subjects who have severe cardiovascular disease. 17. Subjects who have uncontrolled or severe illness. 18. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP. 19. Subjects with a known history of autoimmune diseases. 20. Subjects who have a history of immunodeficiency disease. 21. Subjects with HIV infection, active HBV or HCV infection. 22. Child-bearing potential female who have positive results in pregnancy. test within 7 days before the first dose or are lactating. 23. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 24. Subject who is judged as not eligible to participate in this study by the investigator.

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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

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Shanghai East Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200123, China

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