Testing LM-24C5 for 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 clinical trial evaluates the safety and tolerability of LM-24C5 in patients with advanced solid tumors. It aims to determine the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) for this treatment. Participants must have confirmed recurrent or refractory tumors and have either progressed on or are intolerable to standard therapies. The study will involve multiple locations to assess the drug's effectiveness across diverse patient populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures.
2. Aged ≥18 years old when sign the ICF, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
4. Life expectancy ≥ 3 months.
5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
6. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.
7. At least one measurable lesion according to RECIST v1.1.
8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria:

1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
2. Any prior treatments towards the investigational target.
3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.
4. Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.
5. Subjects with uncontrolled pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.
9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C5.
10. Subjects with the known history of autoimmune disease.
11. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
13. Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.
14. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C5.
15. Subjects who have severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection
17. Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
18. HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception:
19. Subjects who have other active malignancies which are likely to require the treatment.
20. Child-bearing potential female who have positive results in pregnancy test or are lactating.
21. Subjects who have psychiatric illness or disorders that may preclude study compliance.
22. Subject who is judged as not eligible to participate in this study by the investigator.

Where it's running

• Ocala Oncology
  Ocala, Florida, United States Recruiting
• University of Southern California (USC) - Norris Comprehensive Cancer Center
  Los Angeles, California, United States Not yet recruiting
• Indiana University Melvan and Bren Simon Cancer Center
  Indianapolis, Indiana, United States Not yet recruiting
• The Christ Hospital
  Cincinnati, Ohio, United States Not yet recruiting
• Mary Crowley Cancer Research Center
  Dallas, Texas, United States Not yet recruiting
• Virginia Cancer Specialists, P.C.
  Fairfax, Virginia, United States Not yet recruiting

Study contacts

• Study coordinator: Alex Yuan
• Email: alexyuan@lanovamed.com
• Phone: +8615901815211

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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.