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

NCT ID: NCT05199753

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2024-12-31

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LM-108 Dose Escalation

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

Administered intravenously

LM-108 Dose Expansion

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

Administered intravenously

LM-108 combination dose escalation

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

Administered intravenously

An Anti-PD-1 Antibody

Intervention Type: DRUG

Administered intravenously

LM-108 combination dose expansion

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

Administered intravenously

An Anti-PD-1 Antibody

Intervention Type: DRUG

Administered intravenously

Interventions

LM-108

Administered intravenously

Intervention Type: DRUG

An Anti-PD-1 Antibody

Administered intravenously

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LaNova Australia Pty Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Blacktown Hospital

Sydney, New South Wales, Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

ICON Cancer Centre

South Brisbane, Queensland, Australia

Cabrini Health Limited

Malvern, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

One Clinical Research Pty Ltd.

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

LM108-01-101

Identifier Type: -

Identifier Source: org_study_id