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

Last updated: October 9, 2024
Sponsor: LaNova Australia Pty Limited
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

LM-108

An Anti-PD-1 Antibody

Clinical Study ID

NCT05199753
LM108-01-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

  2. Histological or cytological confirmation of recurrent or refractory advanced solidtumours, and have progressed on standard therapy, or are intolerable for availablestandard therapy, or there is no available standard therapy.

  3. At least one measurable disease for expansion cohorts per Response EvaluationCriteria in Solid Tumours (RECIST) v1.1.

  4. Subjects must show appropriate organ and marrow function in laboratory examinationswithin 7 days prior to the first dose

Exclusion

Key Exclusion Criteria:

  1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1of CTCAE v5.0

  2. Uncontrolled tumour-related pain

  3. Known central nervous system (CNS)

  4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: LM-108
Phase: 1/2
Study Start date:
March 16, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Blacktown Hospital

    Sydney, New South Wales NSW 2148
    Australia

    Active - Recruiting

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland QLD 4575
    Australia

    Active - Recruiting

  • ICON Cancer Centre

    South Brisbane, Queensland QLD 4101
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia SA 5042
    Australia

    Site Not Available

  • Cabrini Health Limited

    Malvern, Victoria VIC 3144
    Australia

    Active - Recruiting

  • Alfred Hospital

    Melbourne, Victoria VIC 3004
    Australia

    Active - Recruiting

  • One Clinical Research Pty Ltd.

    Nedlands, Western Australia WA 6009
    Australia

    Active - Recruiting

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