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NCT Number: NCT07694765

A Study 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.

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Key information

Conditions

Malignant Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Macquarie University, North Ryde, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
  • Adequate organ and bone marrow function as defined by protocol.
  • Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion criteria

  • Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
  • Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
  • Participants with uncontrolled tumour-related pain.
  • Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
  • Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
  • Participants who have severe cardiovascular disease.
  • Participants who have uncontrolled or severe illness.
  • Participants who have a history of immunodeficiency disease.
  • Participants with a known history of autoimmune disease.
  • Participants who have other active malignancies which are likely to require the treatment.
  • Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • Participants who have psychiatric illness or disorders that may preclude study compliance.
  • Participants who is judged as not eligible to participate in this study by the investigator.

Treatment and study plan

LM-364 for injection

Drug

Q3W, Intravenous Drip

Tislelizumab

Drug

Q3W, Intravenous Drip

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Time frame: 78 weeks

    Phase I

  2. Incidence of Treatment-Emergent Adverse Events (AEs)

    Time frame: 78 weeks

    Phase I

  3. Incidence of serious adverse events (SAEs)

    Time frame: 78 weeks

    Phase I

  4. Temperature (Celsius)

    Time frame: 78 weeks

    Phase I

  5. Pulse in BPM(Beat per Minute)

    Time frame: 78 weeks

    Phase I

  6. Blood Pressure in mmHg

    Time frame: 78 weeks

    Phase I

  7. Weight in Kg

    Time frame: 78 weeks

    Phase I

  8. Height in centimeters

    Time frame: 78 weeks

    Phase I

  9. Blood Routine examination -> Complete Blood Count

    Time frame: 78 weeks

    Phase I

  10. Urine Routine examination ->Urinalysis

    Time frame: 78 weeks

    Phase I

  11. Blood Biochemistry test -> Electrolytes and Metabolic Parameters

    Time frame: 78 weeks

    Phase I

  12. Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT),

    Time frame: 78 weeks

    Phase I

  13. Pregnancy test

    Time frame: 78 weeks

    Phase I

  14. Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4)

    Time frame: 78 weeks

    Phase I

  15. Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage

    Time frame: 78 weeks

    Phase I

  16. 12-lead electrocardiogram (ECG) in HR

    Time frame: 78 weeks

    Phase I

  17. 12-lead electrocardiogram (ECG) in RR

    Time frame: 78 weeks

    Phase I

  18. 12-lead electrocardiogram (ECG) in QRS

    Time frame: 78 weeks

    Phase I

  19. 12-lead electrocardiogram (ECG) in QT

    Time frame: 78 weeks

    Phase I

  20. 12-lead electrocardiogram (ECG) in QTcF

    Time frame: 78 weeks

    Phase I

  21. ECOG(Eastern Cooperative Oncology Group) score

    Time frame: 78 weeks

    Phase I

  22. Objective Response Rate (ORR)

    Time frame: 130 weeks

    Phase II

Secondary outcomes

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

    Time frame: 130 weeks

    Phase I/II

  2. PK Parameter:Time of Maximum Observed Concentration (Tmax)

    Time frame: 130 weeks

    Phase I/II

  3. PK Parameter: Area Under the Concentration-time Curve (AUC)

    Time frame: 130 weeks

    Phase I/II

  4. PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)

    Time frame: 130 weeks

    Phase I/II

  5. PK Parameter: Steady State Minimum Concentration (Cmin,ss)

    Time frame: 130 weeks

    Phase I/II

  6. PK Parameter: Systemic Clearance at Steady State (CLss)

    Time frame: 130 weeks

    Phase I/II

  7. PK Parameter: Accumulation Ratio (Rac)

    Time frame: 130 weeks

    Phase I/II

  8. PK Parameter: Elimination Half-life (t1/2)

    Time frame: 130 weeks

    Phase I/II

  9. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Time frame: 130 weeks

    Phase I/II

  10. PK Parameter: Degree of Fluctuation (DF)

    Time frame: 130 weeks

    Phase I/II

  11. Immunogenicity testing->Anti-Drug Antibody test

    Time frame: 130 weeks

    Phase I/II

  12. Objective Response Rate (ORR)

    Time frame: 130 weeks

    Phase I/II

  13. Duration of Response (DOR) in Month

    Time frame: 130 weeks

    Phase I/II

  14. Disease control rate (DCR) in percentage

    Time frame: 130 weeks

    Phase I/II

  15. Progression-free survival (PFS) in Month

    Time frame: 130 weeks

    Phase I/II

  16. Overall survival (OS) in Month

    Time frame: 130 weeks

    Phase I/II

  17. Changes of target lesions from baseline in Millimeter

    Time frame: 130 weeks

    Phase I/II

  18. Incidence of adverse events (AEs)

    Time frame: 130 weeks

    Phase II

  19. Incidence of serious adverse events (SAEs)

    Time frame: 130 weeks

    Phase II

  20. Temperature (Celsius)

    Time frame: 130 weeks

    Phase II

  21. Pulse in BPM(Beat per Minute)

    Time frame: 130 weeks

    Phase II

  22. Blood Pressure in mmHg

    Time frame: 130 weeks

    Phase II

  23. Weight in Kg

    Time frame: 130 weeks

    Phase II

  24. Height in centimeters

    Time frame: 130 weeks

    Phase II

  25. Blood Routine examination -> Complete Blood Count

    Time frame: 130 weeks

    Phase II

  26. Urine Routine examination ->Urinalysis

    Time frame: 130 weeks

    Phase II

  27. Blood Biochemistry test -> Electrolytes and Metabolic Parameters

    Time frame: 130 weeks

    Phase II

  28. Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR)

    Time frame: 130 weeks

    Phase II

  29. Pregnancy test

    Time frame: 130 weeks

    Phase II

  30. Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free

    Time frame: 130 weeks

    Phase II

  31. Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage

    Time frame: 130 weeks

    Phase II

  32. ECOG(Eastern Cooperative Oncology Group) score

    Time frame: 130 weeks

    Phase II

  33. 12-lead electrocardiogram (ECG) in HR

    Time frame: 130 weeks

    Phase II

  34. 12-lead electrocardiogram (ECG) in RR

    Time frame: 130 weeks

    Phase II

  35. 12-lead electrocardiogram (ECG) in PR

    Time frame: 130 weeks

    Phase II

  36. 12-lead electrocardiogram (ECG) in QRS

    Time frame: 130 weeks

    Phase II

  37. 12-lead electrocardiogram (ECG) in QT

    Time frame: 130 weeks

    Phase II

  38. 12-lead electrocardiogram (ECG) in QTcF

    Time frame: 130 weeks

    Phase II

  39. Biomarker test -> Tumor tissue biomarker test

    Time frame: 130 weeks

    Phase I/II

  40. QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction)

    Time frame: 12 weeks

    Phase I

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Yuan

CONTACT

[email protected]

+8615901815211

Sponsors and collaborators

Lead sponsor

LaNova Medicines Limited

Industry

Registry information

Official study 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-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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