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RecruitingLast updated: 19 December 2025

LM350-01-101: Evaluating how safe and effective the targeted drug LM-350 is in people with advanced solid cancers who have progressed on prior treatment or have no standard treatment availableA 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-350 in Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

LM350-01-101

Clinical summary

Summary

This study has two stages.

Phase I Dose Escalation Stage
This stage will assess how safe and tolerable the drug LM-350 is in people with advanced solid cancers. Researchers will study different dose levels of the drug to determine the maximum tolerated dose or optimal biological dose, and explore the relationship between the biomarkers and the anti-tumour activity of LM-350.

Phase II Dose Expansion Stage
This stage will assess the initial anti-cancer activity of LM-350 in people with advanced solid cancers.

Conditions

This trial is treating people with advanced solid cancers who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is not available

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

LaNova Medicines Limited

Scientific 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-350 in Patients With Advanced Solid Tumors

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