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Clinical Trial 21701

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT05215574

Phase: Phase I
Principal Investigator: Kim, Richard

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Overview

Study Title

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination with Pembrolizumab 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 to select the RP2D/schedule based on all available clinical data obtained from the Phase 1 study * Part 1b: To assess the safety and tolerability of NGM831 in combination with pembrolizumab to select the combination RP2D/schedule based on all available clinical data obtained from the Phase 1 study Secondary Objectives * To characterize the single and/or multiple dose PK of NGM831 and to characterize the multiple dose PK of NGM831 in combination with pembrolizumab * To evaluate the immunogenicity of NGM831 * To evaluate preliminary antitumor activity of NGM831 monotherapy and in combination with pembrolizumab

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

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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