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

NCT07694765 | Not Yet Recruiting Phase 1

• 1 other identifier: LM364-01-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (22)

• Incidence of dose-limiting toxicity (DLT)

  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

• 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

• Height in centimeters

  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

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

  Phase I

  78 weeks

• Pregnancy test

  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

• 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

• Objective Response Rate (ORR)

  Phase II

  130 weeks

Secondary Outcomes (40)

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

  130 weeks

• PK Parameter:Time of Maximum Observed Concentration (Tmax)

  130 weeks

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

  130 weeks

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

  130 weeks

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

  130 weeks

Study Arms (2)

LM-364 Monotherapy

EXPERIMENTAL

Drug: LM-364 for injection

LM-364 Combination Therapy

EXPERIMENTAL

Drug: LM-364 for injection; Drug: Tislelizumab

Interventions

LM-364 for injection DRUG

Q3W, Intravenous Drip

LM-364 Combination Therapy; LM-364 Monotherapy

Tislelizumab DRUG

Q3W, Intravenous Drip

LM-364 Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (3)

Macquarie University

North Ryde, New South Wales, Australia

Location

Cancer Care Wollongong Hospital

Wollongong, New South Wales, Australia

Location

Icon Cancer Centre South Brisbane

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Injections; tislelizumab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

AU (3)