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

NCT 05199753

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.

Intervention / Treatment 

  • DrugLM-108
  • DrugAn Anti-PD-1 Antibody

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.

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