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

An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors

This trial tests whether giving LM-24C5 together with other therapies is safe and helps adults (18–80) who have CEACAM5-positive advanced solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: LaNova Medicines Limited (Industry-sponsored)
• Drugs / interventions: immunotherapy, prednisone
• Locations: 2 sites (Fuzhou, Fujian and 1 other locations)
• Trial ID: NCT07387081 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically or cytologically confirmed recurrent or refractory advanced solid tumors that are CEACAM5-positive, ECOG 0–1, with at least one evaluable lesion and adequate organ function are ideal candidates.

Not a fit: Patients who are CEACAM5-negative, have poor performance status, significant organ dysfunction, recent other active malignancies, or who cannot travel to the study sites are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the regimen could provide a new targeted treatment option for CEACAM5-positive advanced solid tumor patients that may shrink tumors or delay progression.

How similar studies have performed: LM-24C5 is an investigational agent with limited published clinical outcome data, while other CEACAM5-targeting approaches have shown mixed early-stage results but no clear large-scale success yet.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian and 1 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Mengmeng Liu

Conditions Advanced Solid Tumor Cancer