RECRUITING

A Study of LM-24C5 For Advanced Solid Tumors

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2023-12-20

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06187402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Alex Yuan

CONTACT

+8615901815211

alexyuan@lanovamed.com

Paul Kong

CONTACT

+8613564682439

paulkong@lanovamed.com

Principal Investigator

Terry Pang

STUDY_DIRECTOR

LaNova

Study Locations (Sites)

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

Los Angeles, California, 90089

United States

Ocala Oncology

Ocala, Florida, 34474

United States

Indiana University Melvan and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Mary Crowley Cancer Research Center

Dallas, Texas, 75230

United States

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: LaNova Medicines Limited

Terry Pang, STUDY_DIRECTOR, LaNova

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor