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Brief Title: NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: 831-IO-101
  • Secondary ID: KEYNOTE-E13
  • NTC ID: NCT05215574
  • Sponsor: NGM Biopharmaceuticals, Inc

BRIEF SUMMARY

Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors

  • Overall Status
    Recruiting
  • Start Date
    March 31, 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: Incidence of Adverse Events

Primary Outcome 2 - Timeframe: Baseline up to Approximately 24 months

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

Primary Outcome 3 - Timeframe: Baseline up to Approximately 24 months

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 Carcinoma
  • 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, 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.
Exclusion Criteria:
•Prior treatment targeting ILT3.

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: NGM831@ngmbio.com

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Medical Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: N/A
Facility: The Angeles Clinic
Los Angeles, California 90025
United States
Status: Recruiting Contact: N/A
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: N/A
Facility: Next Oncology
Austin, Texas 78758
United States
Status: Recruiting Contact: N/A
Facility: The University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A