Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours

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 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LM-108; Drug: An Anti-PD-1 Antibody

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: LaNova PM; Phone Number: +8615901815211; Email: alexyuan@lanovamed.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Hospital
      • Contact: Site 02
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Recruiting
      • Sunshine Coast University Private Hospital
      • Contact: Site 07
    • South Brisbane, Queensland, Australia, QLD 4101
      • Recruiting
      • ICON Cancer Centre
      • Contact: Site 04
  • Victoria
    • Malvern, Victoria, Australia, VIC 3144
      • Recruiting
      • Cabrini Health Limited
      • Contact: Site 03
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • Alfred Hospital
      • Contact: Site 05
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • One Clinical Research Pty Ltd.
      • Contact: Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-108 Dose Escalation	Drug: LM-108; Administered intravenously
Experimental: LM-108 Dose Expansion	Drug: LM-108; Administered intravenously
Experimental: LM-108 combination dose escalation	Drug: LM-108; Administered intravenously; Drug: An Anti-PD-1 Antibody; Administered intravenously
Experimental: LM-108 combination dose expansion	Drug: LM-108; Administered intravenously; Drug: An Anti-PD-1 Antibody; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	126 weeks
Incidence of serious adverse event (SAE)	126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.	126 weeks
Incidence of dose-limiting toxicity (DLT)	126 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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: Time of Maximum Observed Concentration (Tmax) 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: Steady State Minimum Concentration (Cmin, ss)	126 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)	126 weeks
PK Parameter: Accumulation Ratio (Rac)	126 weeks
PK Parameter: Elimination Half-life (t 1/2)	126 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)	126 weeks
PK Parameter: Degree of Fluctuation (DF)	126 weeks

Collaborators and Investigators

• Sponsor: LaNova Australia Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: LM108-01-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No