A Study of LM-350 in Subjects With Advanced Solid Tumours

Not Applicable

Not yet recruiting

• Conditions: Malignant Tumors
• Interventions: Drug: LM-350 for injection

• Registration Number: NCT07112222
• Lead Sponsor: LaNova Medicines Limited

Brief Summary

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350.

For Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study Start: 2025-07-31
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2028-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participant must be ≥18 years or the legal age of consent at the time of signing the ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancy ≥ 3 months.
5. Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
6. Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy could be provided for biomarker analysis.
7. Must have at least one measurable lesion according to RECIST v1.1.
8. Adequate organ and bone marrow function as defined by protocol.
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-350.
2. Subjects who have received treatment with the same targeting.
3. Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.
4. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
5. Subjects with uncontrolled tumour-related pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have clinically uncontrollable third-space fluid accumulation.
8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
9. Subjects who take systemic corticosteroids (≥ 10 mg/day of prednisone or equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dose of LM-350.
10. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
11. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.
12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.
13. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-350.
14. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-350.
15. Subjects who have severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness.
17. Subjects who have a history of immunodeficiency disease.
18. HIV infection, active infection including tuberculosis, HBV and HCV infection.
19. Subjects who have other active malignancies which are likely to require the treatment.
20. Spinal cord compression, symptomatic and unstable brain metastases.
21. Child-bearing potential female who have positive results in pregnancy test or are lactating.
22. Subjects who have psychiatric illness or disorders that may preclude study compliance.
23. Subject who is judged as not eligible to participate in this study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I Dose Escalation Part and Dose Confirmation Part	LM-350 for injection	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limitingtoxicity (DLT)	78 weeks	Phase I
Incidence of Treatment-Emergent Adverse Events (AEs)	78 weeks	Phase I
Incidence of serious adverse events (SAEs)	78 weeks	Phase I
Temperature (Celsius)	78 weeks	Phase I
Pulse in BPM(Beat per Minute)	78 weeks	Phase I
Blood Pressure in mmHg	78 weeks	Phase I
Weight in Kg	78 weeks	Phase I
Height in centimeter	78 weeks	Phase I
Blood Routine examination -> Complete Blood Count	78 weeks	Phase I
Urine Routine examination ->Urinalysis	78 weeks	Phase I
Blood Biochemistry test -> Electrolytes and Metabolic Parameters	78 weeks	Phase I
Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized	78 weeks	Phase I
Thyroid function test-For the detection of Thyroid-stimulating hormone (TSH), free T3, free T4	78 weeks	Phase I
Pregnancy test	78 weeks	Phase I
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage	78 weeks	Phase I
12-lead electrocardiogram (ECG) in HR	78 weeks	Phase I
12-lead electrocardiogram (ECG) in RR	78 weeks	Phase I
12-lead electrocardiogram (ECG) in QRS	78 weeks	Phase I
12-lead electrocardiogram (ECG) in QT	78 weeks	Phase I
12-lead electrocardiogram (ECG) in QTcF	78 weeks	Phase I
ECOG(Eastern Cooperative Oncology Group) score	78 weeks	Phase I
Objective Response Rate (ORR)	130 weeks	Phase II

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)	130 weeks	Phase I/II
PK Parameter:Time of Maximum Observed Concentration (Tmax)	130 weeks	Phase I/II
PK Parameter: Area Under the Concentration-time Curve(AUC)	130 weeks	Phase I/II
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)	130 weeks	Phase I/II
PK Parameter: Steady State Minimum Concentration(Cmin,ss)	130 weeks	Phase I/II
PK Parameter: Systemic Clearance at Steady State (CLss)	130 weeks	Phase I/II
PK Parameter: Accumulation Ratio (Rac)	130 weeks	Phase I/II
PK Parameter: Elimination Half-life (t1/2)	130 weeks	Phase I/II
PK Parameter: Volume of Distribution at Steady-State (Vss)	130 weeks	Phase I/II
PK Parameter: Degree of Fluctuation (DF)	130 weeks	Phase I/II
Immunogenicity testing->Anti-Drug Antibody test	130 weeks	Phase I/II
Objective Response Rate (ORR)	130 weeks	Phase I
Duration of Response (DOR) in Month	130 weeks	Phase I/II
Disease control rate (DCR) in percentage	130 weeks	Phase I/II
Progression-free survival (PFS) in Month	130 weeks	Phase I/II
Changes of target lesions from baseline in Millimeter	130 weeks	Phase I/II
Incidence of adverse events (AEs)	130 weeks	Phase II
Incidence of serious adverse events (SAEs)	130 weeks	Phase II
Temperature (Celsius)	130 weeks	Phase II
Pulse in BPM(Beat per Minute)	130 weeks	Phase II
Blood Pressure in mmHg	130 weeks	Phase II
Weight in Kg	130 weeks	Phase II
Height in centimeter	130 weeks	Phase II
Blood Routine examination -> Complete Blood Count	130 weeks	Phase II
Urine Routine examination ->Urinalysis	130 weeks	Phase II
Blood Biochemistry test -> Electrolytes and Metabolic Parameters	130 weeks	Phase II
Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR)	130 weeks	Phase II
Thyroid function test-For the detection of Thyroid-stimulating hormone (TSH), free T3, free T4	130 weeks	Phase II
Pregnancy test	130 weeks	Phase II
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage	130 weeks	Phase II
ECOG(Eastern Cooperative Oncology Group) score	130 weeks	Phase II
12-lead electrocardiogram (ECG) in HR	130 weeks	Phase II
12-lead electrocardiogram (ECG) in RR	130 weeks	Phase II
12-lead electrocardiogram (ECG) in PR	130 weeks	Phase II
12-lead electrocardiogram (ECG) in QRS	130 weeks	Phase II
12-lead electrocardiogram (ECG) in QT	130 weeks	Phase II
12-lead electrocardiogram (ECG) in QTcF	130 weeks	Phase II
Biomarker test -> Tumor tissue biomarker test	130 weeks	Phase I/II

Trial Locations

Locations (1)

Peninsula and South Eastern Haematology and Oncology Group; 🇦🇺 Frankston, Victoria, Australia