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Purpose

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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.

Exclusion Criteria

  • Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NGM707 Monotherapy Dose Escalation 		Part 1a Single Agent Dose Escalation
  • Drug: NGM707
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Experimental
NGM707 Combination Dose Finding with pembrolizumab 		Part 1b NGM707 plus pembrolizumab
  • Drug: NGM707 plus pembrolizumab
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Monotherapy Dose Expansion Arm A 		NGM707 in RCC
  • Drug: NGM707
    Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Monotherapy Dose Expansion Arm B 		NGM707 in CRC
  • Drug: NGM707
    Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Monotherapy Dose Expansion Arm C 		NGM707 in Ovarian Cancer
  • Drug: NGM707
    Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Combination Dose Expansion Arm E 		NGM707 with pembrolizumab in NSCLC
  • Drug: NGM707 plus pembrolizumab
    Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Combination Dose Expansion Arm F 		NGM707 with pembrolizumab in SCCHN
  • Drug: NGM707 plus pembrolizumab
    Drug: NGM707 Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
NGM Site 007

More Details

Status
Recruiting
Sponsor
NGM Biopharmaceuticals, Inc

Study Contact

NGM Medical Director
(650) 243-5555
NGM707@ngmbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.