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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05199753
Other study ID # LM108-01-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 16, 2022
Est. completion date June 2024

Study information

Verified date September 2023
Source LaNova Medicines Limited
Contact LaNova PM
Phone +8615901815211
Email alexyuan@lanovamed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LM-108
Administered intravenously
An Anti-PD-1 Antibody
Administered intravenously

Locations

Country Name City State
Australia Sunshine Coast University Private Hospital Birtinya Queensland
Australia Cabrini Health Limited Malvern Victoria
Australia Alfred Hospital Melbourne Victoria
Australia One Clinical Research Pty Ltd. Nedlands Western Australia
Australia ICON Cancer Centre South Brisbane Queensland
Australia Blacktown Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
LaNova Australia Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) 126 weeks
Primary Incidence of dose-limiting toxicity (DLT) 126 weeks
Primary Incidence of serious adverse event (SAE) 126 weeks
Primary Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. 126 weeks
Secondary Incidence of anti-drug antibodies to LM-108 126 weeks
Secondary Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 126 weeks
Secondary PK Parameter: Minimum Observed Concentration (Cmin) for LM-108 126 weeks
Secondary PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 126 weeks
Secondary PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 126 weeks
Secondary PK Parameter: Steady State Maximum Concentration (Cmax,ss) 126 weeks
Secondary PK Parameter: Steady State Minimum Concentration (Cmin, ss) 126 weeks
Secondary PK Parameter: Systemic Clearance at Steady State (CLss) 126 weeks
Secondary PK Parameter: Accumulation Ratio (Rac) 126 weeks
Secondary PK Parameter: Elimination Half-life (t 1/2) 126 weeks
Secondary PK Parameter: Volume of Distribution at Steady-State (Vss) 126 weeks
Secondary PK Parameter: Degree of Fluctuation (DF) 126 weeks
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