Evaluating LM-108 for advanced solid tumors

A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours

This study is testing a new treatment called LM-108 for people with advanced solid tumors to see if it is safe and effective, both on its own and with another medication.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LaNova Medicines Limited (industry)
• Locations: 6 sites (Sydney, New South Wales and 5 other locations)
• Trial ID: NCT05199753 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase I/II, open-label, multi-centre study designed to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of LM-108, both as a standalone treatment and in combination with an anti-PD-1 antibody. The study involves dose escalation and expansion cohorts for subjects with advanced solid tumors who have either progressed on standard therapies or have no available treatment options. Participants will be monitored for measurable disease response according to established criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals with recurrent or refractory advanced solid tumors who have an ECOG performance status of 0-1.

Not a fit: Patients with uncontrolled tumor-related pain, known CNS involvement, or those who have not recovered from adverse effects of prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies involving anti-PD-1 therapies have shown promising results, suggesting potential for success with this novel combination approach.

Eligibility criteria

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose

Key Exclusion Criteria:

1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
2. Uncontrolled tumour-related pain
3. Known central nervous system (CNS)
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
5. Use of inhaled corticosteroids
6. Known history of autoimmune disease
7. Use of any live attenuated vaccines within 28 days
8. Have severe cardiovascular disease
9. Uncontrolled or severe illness
10. History of immunodeficiency disease
11. Active malignancies which are likely to require the treatment.
12. Child-bearing potential female
13. Have psychiatric illness or disorders

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Sydney, New South Wales and 5 other locations

• Blacktown Hospital — Sydney, New South Wales, Australia (RECRUITING)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (RECRUITING)
• ICON Cancer Centre — South Brisbane, Queensland, Australia (RECRUITING)
• Cabrini Health Limited — Malvern, Victoria, Australia (RECRUITING)
• Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• One Clinical Research Pty Ltd. — Nedlands, Western Australia, Australia (RECRUITING)

Study contacts

• Study coordinator: LaNova PM

Conditions: Advanced Solid Tumor