Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
- Registration Number
- NCT05199753
- Lead Sponsor
- LaNova Australia Pty Limited
- 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-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description LM-108 Dose Escalation LM-108 - LM-108 combination dose escalation An Anti-PD-1 Antibody - LM-108 Dose Expansion LM-108 - LM-108 combination dose escalation LM-108 - LM-108 combination dose expansion An Anti-PD-1 Antibody - LM-108 combination dose expansion LM-108 -
- Primary Outcome Measures
Name Time Method Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. 126 weeks Incidence of adverse events (AEs) 126 weeks Incidence of dose-limiting toxicity (DLT) 126 weeks Incidence of serious adverse event (SAE) 126 weeks
- Secondary Outcome Measures
Name Time Method PK Parameter: Volume of Distribution at Steady-State (Vss) 126 weeks PK Parameter: Degree of Fluctuation (DF) 126 weeks Incidence of anti-drug antibodies to LM-108 126 weeks Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 126 weeks PK Parameter: Minimum Observed Concentration (Cmin) for LM-108 126 weeks PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 126 weeks PK Parameter: Steady State Maximum Concentration (Cmax,ss) 126 weeks PK Parameter: Accumulation Ratio (Rac) 126 weeks PK Parameter: Steady State Minimum Concentration (Cmin, ss) 126 weeks PK Parameter: Systemic Clearance at Steady State (CLss) 126 weeks PK Parameter: Elimination Half-life (t 1/2) 126 weeks PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 126 weeks
Trial Locations
- Locations (6)
ICON Cancer Centre
🇦🇺South Brisbane, Queensland, Australia
Sunshine Coast University Private Hospital
🇦🇺Birtinya, Queensland, Australia
Blacktown Hospital
🇦🇺Sydney, New South Wales, Australia
Cabrini Health Limited
🇦🇺Malvern, Victoria, Australia
One Clinical Research Pty Ltd.
🇦🇺Nedlands, Western Australia, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia