A Study of LM-24C5 For Advanced Solid Tumors

Last updated: September 7, 2025
Sponsor: LaNova Medicines Limited
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

LM-24C5

Clinical Study ID

NCT06187402
LM24C5-01-101
  • Ages > 18
  • All Genders

Study Summary

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who are fully informed of the purpose, nature, method and possible adversereactions of the study, and are willing to participate in the study and sign theinformed 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 nodeterioration within 2 weeks prior to the first dose.

  4. Life expectancy ≥ 3 months.

  5. Subjects must have histological or cytological confirmation of recurrent orrefractory advanced solid tumors, and have progressed on standard therapy, or areintolerable for available standard therapy, or there is no available standardtherapy.

  6. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimumrequirements.

  7. At least one measurable lesion according to RECIST v1.1.

  8. Subjects must show appropriate organ and marrow function in laboratory examinationswithin 7 days prior to the first dose.

  9. Subjects who are able to communicate well with investigators and understand andadhere to the requirements of this study.

Exclusion

Exclusion Criteria:

  1. Participate in any other clinical trial within 28 days prior to 1st dosing ofLM-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 andimmunotherapy, etc. the following treatments have different time limits.

  4. Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 ofCTCAE 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 ascitesrequiring recurrent drainage procedures.

  8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment thatcontains any monoclonal antibody.

  9. Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) orother systemic immunosuppressive medications within 2 weeks prior to the firstdosing 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 pneumonitison 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 orvitamin K antagonists for presence of active thromboembolic disease.

  14. Subjects who received major surgery or interventional treatment within 28 days priorto 1st dosing of LM-24C5.

  15. Subjects who have severe cardiovascular disease.

  16. Subjects who have uncontrolled or severe illness, including but not limited toongoing or active infection

  17. Subjects who have a history of immunodeficiency disease, including other acquired orcongenital immunodeficiency diseases, or organ transplantation, or allogeneic bonemarrow transplantation, or autologous hematopoietic stem cell transplantation.

  18. HIV infection, active infection including tuberculosis, HBV and HCV infection, withthe exception:

  19. Subjects who have other active malignancies which are likely to require thetreatment.

  20. Child-bearing potential female who have positive results in pregnancy test or arelactating.

  21. Subjects who have psychiatric illness or disorders that may preclude studycompliance.

  22. Subject who is judged as not eligible to participate in this study by theinvestigator.

Study Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: LM-24C5
Phase: 1/2
Study Start date:
December 20, 2023
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • University of Southern California (USC) - Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Site Not Available

  • University of Southern California (USC) - Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90089
    United States

    Site Not Available

  • Ocala Oncology

    Ocala, Florida 34474
    United States

    Site Not Available

  • Ocala Oncology

    Ocala 4166673, Florida 4155751 34474
    United States

    Active - Recruiting

  • Indiana University Melvan and Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Melvan and Bren Simon Cancer Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Mary Crowley Cancer Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Mary Crowley Cancer Research Center

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Virginia Cancer Specialists, P.C.

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, P.C.

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.