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  • Cancer Type: Multiple
  • Study Type: Treatment
  • NCT#: NCT05215574
  • Phase: Phase I
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  • Overview

    Study Title:

    A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

    Summary:

    This study is being conducted to determine the safety and tolerability of NGM831 by itself and in combination with pembrolizumab in advanced or metastatic solid tumors.

    Objective:

    Primary Objectives: Part 1a • To assess safety and tolerability at increasing dose levels of NGM831 monotherapy in successive cohorts of patients with advanced or metastatic solid tumors and inform the expansion dosing regimen(s) based on all available clinical data obtained from the study Part 1b • To assess the safety and tolerability of NGM831 in combination with pembrolizumab and inform the combination expansion dosing regimen(s) based on all available clinical data obtained from the study Part 1c • To assess the safety and tolerability of NGM831 in combination with pembrolizumab and NGM438 and inform the combination expansion dosing regimen(s) based on all available clinical data obtained from the study Secondary Objectives Parts 1a, 1b and 1c • To characterize the single and/or multiple dose PK of NGM831 and to characterize the multiple dose PK of NGM831 in combination with pembrolizumab, and in combination with pembrolizumab and NGM438 • To characterize the multiple dose PK of NGM438 in combination with pembrolizumab and NGM831 (Part 1c only) • To evaluate the immunogenicity of NGM831 and NGM438 • To evaluate preliminary antitumor activity of NGM831 monotherapy, in combination with pembrolizumab, and in combination with pembrolizumab and NGM438

  • Treatments

    Therapies:

    Immunotherapy; Therapy (NOS)

    Medications:

    NGM438 (); NGM831 (); Pembrolizumab (Keytruda)

  • Inclusion Criteria

      Key Inclusion Criteria:
    • Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
    • Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused standard-of-care (SOC) treatments that are perceived to have marginal clinical benefit.
    • Adequate bone marrow, kidney and liver function
    • Performance status of 0 or 1.
    • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
    • Other criteria apply
  • Exclusion Criteria

      Key Exclusion Criteria:
    • Prior treatment targeting ILT3

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