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Trial record 1 of 1 for:    LM24C5-01-101
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A Study of LM-24C5 For Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT06187402
Recruitment Status : Recruiting
First Posted : January 2, 2024
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
LaNova Medicines Limited

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: LM-24C5 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : March 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: LM-24C5 Dose Escalation Drug: LM-24C5
Administered intravenously
Experimental: LM-24C5 Dose Expansion Drug: LM-24C5
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: 60 weeks ]
    Phase 1

  2. Incidence of dose-limiting toxicity (DLT) [ Time Frame: 60 weeks ]
    Phase 1

  3. Incidence of serious adverse event (SAE) [ Time Frame: 60 weeks ]
    Phase 1

  4. Ear Temperature [ Time Frame: 60 weeks ]
    Phase 1

  5. Pulse in BPM(Beat per Minute) [ Time Frame: 60 weeks ]
    Phase 1

  6. Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure) [ Time Frame: 60 weeks ]
    Phase 1

  7. Number of participants with abnormal Hematology test results [ Time Frame: 60 weeks ]
    Phase 1

  8. Number of participants with abnormal Urinalysis test results [ Time Frame: 60 weeks ]
    Phase 1

  9. Number of participants with abnormal Blood Biochemistry test results [ Time Frame: 60 weeks ]
    Phase 1

  10. Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio). [ Time Frame: 60 weeks ]
    Phase 1

  11. Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage [ Time Frame: 60 weeks ]
    Phase 1

  12. 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. [ Time Frame: 60 weeks ]
    Phase 1

  13. ECOG(Eastern Cooperative Oncology Group) score [ Time Frame: 60 weeks ]
    Phase 1

  14. Overall Response Rate (ORR) [ Time Frame: 36 weeks ]
    Phase 2


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  2. PK Parameter:Time of Maximum Observed Concentration (Tmax) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  3. PK Parameter: Area Under the Concentration-time Curve(AUC) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  4. PK Parameter: Steady State Maximum Concentration(Cmax,ss) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  5. PK Parameter: Steady State Minimum Concentration(Cmin,ss) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  6. PK Parameter: Systemic Clearance at Steady State (CLss) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  7. PK Parameter: Accumulation Ratio (Rac) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  8. PK Parameter: Elimination Half-life (t1/2) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  9. PK Parameter: Volume of Distribution at Steady-State (Vss) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  10. PK Parameter: Degree of Fluctuation (DF) [ Time Frame: 96 weeks ]
    Phase 1 and 2

  11. Immunogenicity of LM-24C5 [ Time Frame: 96 weeks ]
    Phase 1 and 2; Anti-Drug antibody and Nab (if necessary) will be tested.

  12. Duration of Response (DOR) in Month [ Time Frame: 96 weeks ]
    Phase 1 and 2

  13. Disease control rate (DCR) in percentage [ Time Frame: 96 weeks ]
    Phase 1 and 2

  14. progression-free survival (PFS) in Month [ Time Frame: 96 weeks ]
    Phase 1 and 2

  15. Overall survival (OS) in Month [ Time Frame: 60 weeks ]
    Phase 1

  16. Changes of target lesions from baseline in Millimeter. [ Time Frame: 96 weeks ]
    Phase 1 and 2

  17. Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) [ Time Frame: 36 weeks ]
    Phase 2

  18. Ear Temperature [ Time Frame: 36 weeks ]
    Phase 2

  19. Pulse in BPM (Beat per Minute) [ Time Frame: 36 weeks ]
    Phase 2

  20. Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure) [ Time Frame: 36 weeks ]
    Phase 2

  21. Number of participants with abnormal Hematology test results [ Time Frame: 36 weeks ]
    Phase 2

  22. Number of participants with abnormal Urinalysis test results [ Time Frame: 36 weeks ]
    Phase 2

  23. Number of participants with abnormal Blood Biochemistry test results [ Time Frame: 36 weeks ]
    Phase 2

  24. Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio). [ Time Frame: 36 weeks ]
    Phase 2

  25. 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. [ Time Frame: 36 weeks ]
    Phase 2

  26. ECOG(Eastern Cooperative Oncology Group) score [ Time Frame: 36 weeks ]
    Phase 2


Other Outcome Measures:
  1. Relationship between the biomarkers and the anti-tumor activity [ Time Frame: 96 weeks ]
    Phase 1 and 2


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06187402


Contacts
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Contact: Alex Yuan +8615901815211 alexyuan@lanovamed.com
Contact: Paul Kong +8613564682439 paulkong@lanovamed.com

Locations
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United States, California
University of Southern California (USC) - Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Heinz-Josef Lenz         
United States, Florida
Ocala Oncology Recruiting
Ocala, Florida, United States, 34474
Contact: Rama Balaraman         
United States, Indiana
Indiana University Melvan and Bren Simon Cancer Center Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mateusz Opyrchal         
United States, Ohio
The Christ Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Alex Starodub         
United States, Texas
Mary Crowley Cancer Research Center Not yet recruiting
Dallas, Texas, United States, 75230
Contact: Minal Barve         
United States, Virginia
Virginia Cancer Specialists, P.C. Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Alexander Spira         
Sponsors and Collaborators
LaNova Medicines Limited
Investigators
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Study Director: Terry Pang LaNova
More Information
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Responsible Party: LaNova Medicines Limited
ClinicalTrials.gov Identifier: NCT06187402    
Other Study ID Numbers: LM24C5-01-101
First Posted: January 2, 2024    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms