New combo therapy targets Hard-to-Treat cancers
NCT ID NCT07387081
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. 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.
-
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
RECRUITINGFuzhou, Fujian, 350014, China
-
Shanghai East Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200123, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers