LM-350 treatment for 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-350 in Patients With Advanced Solid Tumors

This trial will test LM-350, an experimental injectable drug, in adults with advanced solid tumors who have not responded to or cannot receive standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LaNova Medicines Limited (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 4 sites (Wollongong, New South Wales and 3 other locations)
• Trial ID: NCT07112222 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2 interventional trial of LM-350 given by injection in adults with advanced solid tumors. The Phase 1 dose-escalation stage will test escalating doses to define the maximum tolerated dose or optimal biological dose and will collect tumor biopsies and other biomarkers to explore relationships with anti-tumor activity. The Phase 2 expansion stage will give the selected dose to more patients to measure preliminary anti-tumor activity. Key eligibility includes measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ and bone marrow function, and availability of archived or on-treatment tumor tissue for biomarker analysis.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed advanced solid tumors, ECOG 0–1, at least one measurable lesion per RECIST v1.1, adequate organ/bone marrow function, and able to provide tumor tissue are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under 3 months, inadequate organ function, or who cannot provide required tissue samples are unlikely to benefit from this trial.

Why it matters

Potential benefit: If active, LM-350 could shrink tumors or slow disease progression for some patients who have exhausted standard treatment options.

How similar studies have performed: Some early-phase trials of other targeted injectable agents in advanced solid tumors have shown responses, but LM-350 appears to be a novel agent without published clinical efficacy data yet.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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. History of ≥ Grade 3 late diarrhea during or after previous treatment with a topoisomerase inhibitor.
4. Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.
5. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
6. Subjects with uncontrolled tumour-related pain.
7. Subjects with known central nervous system (CNS) or meningeal metastasis.
8. Subjects who have clinically uncontrollable third-space fluid accumulation.
9. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
10. 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.
11. 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.
12. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.
13. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.
14. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of LM-350.
15. Subjects with active or a documented history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).
16. Subjects with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug , orpatients who are currently at the risk of intestinal perforation.
17. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-350.
18. Subjects who have severe cardiovascular disease.
19. Subjects who have uncontrolled or severe illness.
20. Subjects who have a history of immunodeficiency disease.
21. HIV infection, active infection including tuberculosis, HBV and HCV infection.
22. Subjects who have other active malignancies which are likely to require the treatment.
23. Child-bearing potential female who have positive results in pregnancy test or are lactating.
24. Subjects who have psychiatric illness or disorders that may preclude study compliance.
25. Subject who is judged as not eligible to participate in this study by the investigator.

Where this trial is running

Wollongong, New South Wales and 3 other locations

• Cancer Care Wollongong Pty Limited — Wollongong, New South Wales, Australia (Recruiting)
• Cancer Research SA — Adelaide, South Australia, Australia (Recruiting)
• Peninsula and South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Alex Yuan

Conditions Malignant Tumors