Status:
COMPLETED
Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
Lead Sponsor:
LaNova Australia Pty Limited
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-1...
Eligibility Criteria
Inclusion
- Key
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- 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.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
- Key
Exclusion
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
- Known history of autoimmune disease
- Use of any live attenuated vaccines within 28 days
- Have severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency disease
- Active malignancies which are likely to require the treatment.
- Child-bearing potential female
- Have psychiatric illness or disorders
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05199753
Start Date
March 16 2022
End Date
December 31 2024
Last Update
September 12 2025
Active Locations (6)
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1
Blacktown Hospital
Sydney, New South Wales, Australia, NSW 2148
2
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, QLD 4575
3
ICON Cancer Centre
South Brisbane, Queensland, Australia, QLD 4101
4
Cabrini Health Limited
Malvern, Victoria, Australia, VIC 3144