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

NCT05199753 | Completed Phase 1 DMC

• 1 other identifier: LM108-01-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events (AEs)

  126 weeks

• Incidence of dose-limiting toxicity (DLT)

  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

Secondary Outcomes (12)

• 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

Study Arms (4)

LM-108 Dose Escalation

EXPERIMENTAL

Drug: LM-108

LM-108 Dose Expansion

EXPERIMENTAL

Drug: LM-108

LM-108 combination dose escalation

EXPERIMENTAL

Drug: LM-108; Drug: An Anti-PD-1 Antibody

LM-108 combination dose expansion

EXPERIMENTAL

Drug: LM-108; Drug: An Anti-PD-1 Antibody

Interventions

LM-108 DRUG

Administered intravenously

LM-108 Dose Escalation; LM-108 Dose Expansion; LM-108 combination dose escalation; LM-108 combination dose expansion

An Anti-PD-1 Antibody DRUG

Administered intravenously

LM-108 combination dose escalation; LM-108 combination dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LaNova Australia Pty Limited: lead

Study Sites (6)

Blacktown Hospital

Sydney, New South Wales, NSW 2148, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, QLD 4575, Australia

Location

ICON Cancer Centre

South Brisbane, Queensland, QLD 4101, Australia

Location

Cabrini Health Limited

Malvern, Victoria, VIC 3144, Australia

Location

Alfred Hospital

Melbourne, Victoria, VIC 3004, Australia

Location

One Clinical Research Pty Ltd.

Nedlands, Western Australia, WA 6009, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 20, 2022
• Study Start: March 16, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)