A Study of LM-24C5 For Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LM-24C5

• Study Type: Interventional
• Enrollment (Estimated): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alex Yuan; Phone Number: +8615901815211; Email: alexyuan@lanovamed.com
• Study Contact Backup: Name: Paul Kong; Phone Number: +8613564682439; Email: paulkong@lanovamed.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Not yet recruiting
      • University of Southern California (USC) - Norris Comprehensive Cancer Center
      • Contact: Heinz-Josef Lenz
  • Florida
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Ocala Oncology
      • Contact: Rama Balaraman
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University Melvan and Bren Simon Cancer Center
      • Contact: Mateusz Opyrchal
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Not yet recruiting
      • The Christ Hospital
      • Contact: Alex Starodub
  • Texas
    • Dallas, Texas, United States, 75230
      • Not yet recruiting
      • Mary Crowley Cancer Research Center
      • Contact: Minal Barve
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Not yet recruiting
      • Virginia Cancer Specialists, P.C.
      • Contact: Alexander Spira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-24C5 Dose Escalation	Drug: LM-24C5; Administered intravenously
Experimental: LM-24C5 Dose Expansion	Drug: LM-24C5; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Phase 1	60 weeks
Incidence of dose-limiting toxicity (DLT)	Phase 1	60 weeks
Incidence of serious adverse event (SAE)	Phase 1	60 weeks
Ear Temperature	Phase 1	60 weeks
Pulse in BPM(Beat per Minute)	Phase 1	60 weeks
Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)	Phase 1	60 weeks
Number of participants with abnormal Hematology test results	Phase 1	60 weeks
Number of participants with abnormal Urinalysis test results	Phase 1	60 weeks
Number of participants with abnormal Blood Biochemistry test results	Phase 1	60 weeks
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).	Phase 1	60 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage	Phase 1	60 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.	Phase 1	60 weeks
ECOG(Eastern Cooperative Oncology Group) score	Phase 1	60 weeks
Overall Response Rate (ORR)	Phase 2	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)	Phase 1 and 2	96 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)	Phase 1 and 2	96 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)	Phase 1 and 2	96 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)	Phase 1 and 2	96 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)	Phase 1 and 2	96 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)	Phase 1 and 2	96 weeks
PK Parameter: Accumulation Ratio (Rac)	Phase 1 and 2	96 weeks
PK Parameter: Elimination Half-life (t1/2)	Phase 1 and 2	96 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)	Phase 1 and 2	96 weeks
PK Parameter: Degree of Fluctuation (DF)	Phase 1 and 2	96 weeks
Immunogenicity of LM-24C5	Phase 1 and 2; Anti-Drug antibody and Nab (if necessary) will be tested.	96 weeks
Duration of Response (DOR) in Month	Phase 1 and 2	96 weeks
Disease control rate (DCR) in percentage	Phase 1 and 2	96 weeks
progression-free survival (PFS) in Month	Phase 1 and 2	96 weeks
Overall survival (OS) in Month	Phase 1	60 weeks
Changes of target lesions from baseline in Millimeter.	Phase 1 and 2	96 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)	Phase 2	36 weeks
Ear Temperature	Phase 2	36 weeks
Pulse in BPM (Beat per Minute)	Phase 2	36 weeks
Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)	Phase 2	36 weeks
Number of participants with abnormal Hematology test results	Phase 2	36 weeks
Number of participants with abnormal Urinalysis test results	Phase 2	36 weeks
Number of participants with abnormal Blood Biochemistry test results	Phase 2	36 weeks
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).	Phase 2	36 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.	Phase 2	36 weeks
ECOG(Eastern Cooperative Oncology Group) score	Phase 2	36 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between the biomarkers and the anti-tumor activity	Phase 1 and 2	96 weeks

Collaborators and Investigators

• Sponsor: LaNova Medicines Limited
• Investigators: Study Director: Terry Pang, LaNova

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 7, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LM24C5-01-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No