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

Purpose

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

Conditions

  • Mesothelioma
  • Glioblastoma
  • Renal Cell Carcinoma
  • Non Small Cell Lung Cancer
  • Melanoma
  • Pancreatic Ductal Adenocarcinoma
  • Gastric Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Cholangiocarcinoma
  • Breast Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Endocervical Cancer
  • Colorectal Cancer
  • Esophageal Cancer

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 (KEYTRUDA®) 		Part 1b NGM707 plus pembrolizumab (KEYTRUDA®)
  • Drug: NGM707 plus pembrolizumab (KEYTRUDA®)
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Combination Dose Expansion Arm A 		NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC
  • Drug: NGM707 plus pembrolizumab (KEYTRUDA®)
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Combination Dose Expansion Arm B 		NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC
  • Drug: NGM707 plus pembrolizumab (KEYTRUDA®)
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Combination Dose Expansion Arm C 		NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN
  • Drug: NGM707 plus pembrolizumab (KEYTRUDA®)
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Experimental
NGM707 Monotherapy Dose Expansion Arm D 		NGM707 in RCC
  • 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 Monotherapy Dose Expansion Arm E 		NGM707 in CRC
  • 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 Monotherapy Dose Expansion Arm F 		NGM707 in Ovarian
  • Drug: NGM707
    Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

More Details

Status
Active, not recruiting
Sponsor
NGM Biopharmaceuticals, Inc

Study Contact