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Brief Title: NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: 438-IO-101
  • Secondary ID: KEYNOTE-E20
  • NTC ID: NCT05311618
  • Sponsor: NGM Biopharmaceuticals, Inc

BRIEF SUMMARY

Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors

  • Overall Status
    Recruiting
  • Start Date
    May 11, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Patients with Dose-limiting Toxicities

Primary Outcome 1 - Timeframe: Baseline up to 21 Days

Primary Outcome 2 - Measure: Number of Patients with Adverse Events

Primary Outcome 2 - Timeframe: Approximately 24 months

Primary Outcome 3 - Measure: Number of Patients with Clinically Significant Laboratory Abnormalities

Primary Outcome 3 - Timeframe: Approximately 24 months

Primary Outcome 4 - Measure: Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163

Primary Outcome 4 - Timeframe: Baseline up to 15 days

Primary Outcome 5 - Measure: Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9

Primary Outcome 5 - Timeframe: Baseline up to 15 days

Primary Outcome 6 - Measure: Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8

Primary Outcome 6 - Timeframe: Baseline up to 15 days

CONDITION

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

ELIGIBILITY

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 for which the patient was eligible and willing to receive.

- 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 LAIR1

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: (650) 243-5555

Email: NGM438@ngmbio.com

LOCATION

Facility Status Contact
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: N/A
Facility: Mount Sinai Hospital
New York, New York 10029
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A