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

A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: 831-IO-101
  • Secondary ID: N/A
  • NCT ID: NCT05215574
  • Sponsor: NGM Biopharmaceuticals, Inc

BRIEF SUMMARY

Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

  • Overall Status
    Active, not 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

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.

- * 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.

- * 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: N/A

Email: N/A

LOCATION

Facility Status Contact