A Study of LM-24C5 For Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187402
• Other study ID #: LM24C5-01-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 20, 2023
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: LaNova Medicines Limited
• Contact: Alex Yuan
• Phone: +8615901815211
• Email: alexyuan[@]lanovamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: March 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LM-24C5
Administered intravenously

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	Mary Crowley Cancer Research Center	Dallas	Texas
United States	Virginia Cancer Specialists, P.C.	Fairfax	Virginia
United States	Indiana University Melvan and Bren Simon Cancer Center	Indianapolis	Indiana
United States	University of Southern California (USC) - Norris Comprehensive Cancer Center	Los Angeles	California
United States	Ocala Oncology	Ocala	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LaNova Medicines Limited

Country where clinical trial is conducted

United States, 

Outcome

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