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Completed

NCT Number: NCT05199753

Study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Blacktown Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Treatment and study plan

LM-108

Drug

Administered intravenously

An Anti-PD-1 Antibody

Drug

Administered intravenously

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 126 weeks

  2. Incidence of dose-limiting toxicity (DLT)

    Time frame: 126 weeks

  3. Incidence of serious adverse event (SAE)

    Time frame: 126 weeks

  4. Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.

    Time frame: 126 weeks

Secondary outcomes

  1. Incidence of anti-drug antibodies to LM-108

    Time frame: 126 weeks

  2. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108

    Time frame: 126 weeks

  3. PK Parameter: Minimum Observed Concentration (Cmin) for LM-108

    Time frame: 126 weeks

  4. PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108

    Time frame: 126 weeks

  5. PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108

    Time frame: 126 weeks

  6. PK Parameter: Steady State Maximum Concentration (Cmax,ss)

    Time frame: 126 weeks

  7. PK Parameter: Steady State Minimum Concentration (Cmin, ss)

    Time frame: 126 weeks

  8. PK Parameter: Systemic Clearance at Steady State (CLss)

    Time frame: 126 weeks

  9. PK Parameter: Accumulation Ratio (Rac)

    Time frame: 126 weeks

  10. PK Parameter: Elimination Half-life (t 1/2)

    Time frame: 126 weeks

  11. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Time frame: 126 weeks

  12. PK Parameter: Degree of Fluctuation (DF)

    Time frame: 126 weeks

Sponsors and collaborators

Lead sponsor

LaNova Australia Pty Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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