Phase II LM-24C5 treatment for CEACAM5-positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interventional trial gives LM-24C5 in combination with other therapies to adult patients whose tumors express CEACAM5 and who have recurrent or refractory advanced solid tumors. Eligible participants must have an ECOG performance status of 0–1, at least one evaluable lesion, adequate organ and marrow function, and a life expectancy of at least three months. The study will monitor safety and signs of antitumor activity to determine whether the combination produces measurable tumor responses and acceptable toxicity. Treatment is administered at participating hospital sites with regular clinical and laboratory assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Mengmeng Liu
• Email: mengmengliu@lanovamed.com
• Phone: +8613918118040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.