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Malignant TumorsPhase 1/2NCT07694765

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

A Phase 1/2 study testing LM-364 for injection and Tislelizumab in people with Malignant Tumors, run by LaNova Medicines Limited at 3 sites in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Tumors
What is being tested?
LM-364 for injection and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
3 sitesAustralia
Study dates
15 Jul 2026to 31 Dec 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Yuan contact

+8615901815211

alexyuan@lanovamed.com

Australia3 sites

  • Icon Cancer Centre South Brisbane

    Brisbane, Queensland

    Jermaine Coward

  • Macquarie University

    North Ryde, New South Wales

    Dhanusha Sabanathan

  • Cancer Care Wollongong Hospital

    Wollongong, New South Wales

    Udit Nindra

Other trials in Australia

About this study

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-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.

Being tested
LM-364 for injection, Tislelizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-364 for injectionDrug

    Q3W, Intravenous Drip

  • TislelizumabDrug

    Q3W, Intravenous Drip

Study groups in NCT07694765
Study groupRoleWhat they receive
LM-364 MonotherapyExperimentalNot described
Receives: Drug: LM-364 for injection
LM-364 Combination TherapyExperimentalNot described
Receives: Drug: LM-364 for injection; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicity (DLT)

    Phase I

    Measured: 78 weeks

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

    Phase I

    Measured: 78 weeks

  3. Incidence of serious adverse events (SAEs)

    Phase I

    Measured: 78 weeks

  4. Temperature (Celsius)

    Phase I

    Measured: 78 weeks

  5. Pulse in BPM(Beat per Minute)

    Phase I

    Measured: 78 weeks

  6. Blood Pressure in mmHg

    Phase I

    Measured: 78 weeks

  7. Weight in Kg

    Phase I

    Measured: 78 weeks

  8. Height in centimeters

    Phase I

    Measured: 78 weeks

  9. Blood Routine examination -> Complete Blood Count

    Phase I

    Measured: 78 weeks

  10. Urine Routine examination ->Urinalysis

    Phase I

    Measured: 78 weeks

  11. Blood Biochemistry test -> Electrolytes and Metabolic Parameters

    Phase I

    Measured: 78 weeks

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

    Phase I

    Measured: 78 weeks

  13. Pregnancy test

    Phase I

    Measured: 78 weeks

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

    Phase I

    Measured: 78 weeks

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

    Phase I

    Measured: 78 weeks

  16. 12-lead electrocardiogram (ECG) in HR

    Phase I

    Measured: 78 weeks

  17. 12-lead electrocardiogram (ECG) in RR

    Phase I

    Measured: 78 weeks

  18. 12-lead electrocardiogram (ECG) in QRS

    Phase I

    Measured: 78 weeks

  19. 12-lead electrocardiogram (ECG) in QT

    Phase I

    Measured: 78 weeks

  20. 12-lead electrocardiogram (ECG) in QTcF

    Phase I

    Measured: 78 weeks

  21. ECOG(Eastern Cooperative Oncology Group) score

    Phase I

    Measured: 78 weeks

  22. Objective Response Rate (ORR)

    Phase II

    Measured: 130 weeks

Secondary outcomes (40)

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

  7. PK Parameter: Accumulation Ratio (Rac)

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

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

    Phase I/II

    Measured: 130 weeks

  10. PK Parameter: Degree of Fluctuation (DF)

    Phase I/II

    Measured: 130 weeks

  11. Immunogenicity testing->Anti-Drug Antibody test

    Phase I/II

    Measured: 130 weeks

  12. Objective Response Rate (ORR)

    Phase I/II

    Measured: 130 weeks

  13. Duration of Response (DOR) in Month

    Phase I/II

    Measured: 130 weeks

  14. Disease control rate (DCR) in percentage

    Phase I/II

    Measured: 130 weeks

  15. Progression-free survival (PFS) in Month

    Phase I/II

    Measured: 130 weeks

  16. Overall survival (OS) in Month

    Phase I/II

    Measured: 130 weeks

  17. Changes of target lesions from baseline in Millimeter

    Phase I/II

    Measured: 130 weeks

  18. Incidence of adverse events (AEs)

    Phase II

    Measured: 130 weeks

  19. Incidence of serious adverse events (SAEs)

    Phase II

    Measured: 130 weeks

  20. Temperature (Celsius)

    Phase II

    Measured: 130 weeks

  21. Pulse in BPM(Beat per Minute)

    Phase II

    Measured: 130 weeks

  22. Blood Pressure in mmHg

    Phase II

    Measured: 130 weeks

  23. Weight in Kg

    Phase II

    Measured: 130 weeks

  24. Height in centimeters

    Phase II

    Measured: 130 weeks

  25. Blood Routine examination -> Complete Blood Count

    Phase II

    Measured: 130 weeks

  26. Urine Routine examination ->Urinalysis

    Phase II

    Measured: 130 weeks

  27. Blood Biochemistry test -> Electrolytes and Metabolic Parameters

    Phase II

    Measured: 130 weeks

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

    Phase II

    Measured: 130 weeks

  29. Pregnancy test

    Phase II

    Measured: 130 weeks

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

    Phase II

    Measured: 130 weeks

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

    Phase II

    Measured: 130 weeks

  32. ECOG(Eastern Cooperative Oncology Group) score

    Phase II

    Measured: 130 weeks

  33. 12-lead electrocardiogram (ECG) in HR

    Phase II

    Measured: 130 weeks

  34. 12-lead electrocardiogram (ECG) in RR

    Phase II

    Measured: 130 weeks

  35. 12-lead electrocardiogram (ECG) in PR

    Phase II

    Measured: 130 weeks

  36. 12-lead electrocardiogram (ECG) in QRS

    Phase II

    Measured: 130 weeks

  37. 12-lead electrocardiogram (ECG) in QT

    Phase II

    Measured: 130 weeks

  38. 12-lead electrocardiogram (ECG) in QTcF

    Phase II

    Measured: 130 weeks

  39. Biomarker test -> Tumor tissue biomarker test

    Phase I/II

    Measured: 130 weeks

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

    Phase I

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694765
Sponsor's protocol ID
LM364-01-101
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM-364 for injection and Tislelizumab in people with Malignant Tumors, run by LaNova Medicines Limited at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Yuan (+8615901815211, alexyuan@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (DLT) (time frame: 78 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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