A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With 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-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

For Phase I, 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-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.

For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Tumors
• Intervention / Treatment: Drug: LM-364 for injection; Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alex Yuan; Phone Number: +8615901815211; Email: alexyuan@lanovamed.com

Study Locations

• Australia
  • New South Wales
    • North Ryde, New South Wales, Australia
      • Macquarie University
      • Contact: Dhanusha Sabanathan
    • Wollongong, New South Wales, Australia
      • Cancer Care Wollongong Hospital
      • Contact: Udit Nindra
  • Queensland
    • Brisbane, Queensland, Australia
      • Icon Cancer Centre South Brisbane
      • Contact: Jermaine Coward

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participants 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. Adequate organ and bone marrow function as defined by protocol.
6. Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria:

1. Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
2. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
3. Participants with uncontrolled tumour-related pain.
4. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
5. Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
6. Participants who have severe cardiovascular disease.
7. Participants who have uncontrolled or severe illness.
8. Participants who have a history of immunodeficiency disease.
9. Participants with a known history of autoimmune disease.
10. Participants who have other active malignancies which are likely to require the treatment.
11. Child-bearing potential female who have positive results in pregnancy test or are lactating.
12. Participants who have psychiatric illness or disorders that may preclude study compliance.
13. Participants 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: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-364 Monotherapy	Drug: LM-364 for injection; Q3W, Intravenous Drip
Experimental: LM-364 Combination Therapy	Drug: LM-364 for injection; Q3W, Intravenous Drip; Drug: Tislelizumab; Q3W, Intravenous Drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature (Celsius)	Phase I	78 weeks
Pulse in BPM(Beat per Minute)	Phase I	78 weeks
Blood Pressure in mmHg	Phase I	78 weeks
Weight in Kg	Phase I	78 weeks
12-lead electrocardiogram (ECG) in HR	Phase I	78 weeks
12-lead electrocardiogram (ECG) in RR	Phase I	78 weeks
12-lead electrocardiogram (ECG) in QRS	Phase I	78 weeks
12-lead electrocardiogram (ECG) in QT	Phase I	78 weeks
12-lead electrocardiogram (ECG) in QTcF	Phase I	78 weeks
ECOG(Eastern Cooperative Oncology Group) score	Phase I	78 weeks
Incidence of Treatment-Emergent Adverse Events (AEs)	Phase I	78 weeks
Incidence of serious adverse events (SAEs)	Phase I	78 weeks
Blood Routine examination -> Complete Blood Count	Phase I	78 weeks
Urine Routine examination ->Urinalysis	Phase I	78 weeks
Blood Biochemistry test -> Electrolytes and Metabolic Parameters	Phase I	78 weeks
Pregnancy test	Phase I	78 weeks
Objective Response Rate (ORR)	Phase II	130 weeks
Incidence of dose-limiting toxicity (DLT)	Phase I	78 weeks
Height in centimeters	Phase I	78 weeks
Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT),	Phase I	78 weeks
Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4)	Phase I	78 weeks
Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage	Phase I	78 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LaNova Medicines Limited

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; tislelizumab
• Other Study ID Numbers: LM364-01-101

Drug and device information, study documents

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