UnknownPhase 1

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

United States71 participantsStarted 2022-05-11

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Patients with Dose-limiting Toxicities

Timeframe: Baseline up to 21 Days

Number of Patients with Adverse Events

Timeframe: Approximately 24 months

Number of Patients with Clinically Significant Laboratory Abnormalities

Timeframe: Approximately 24 months

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

Timeframe: Baseline up to 15 days

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

Timeframe: Baseline up to 15 days

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

Timeframe: Baseline up to 15 days

Trial details

NCT IDNCT05311618

SponsorNGM Biopharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04

View on ClinicalTrials.gov More Pancreatic Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients with Dose-limiting Toxicities

Timeframe: Baseline up to 21 Days

Number of Patients with Adverse Events

Timeframe: Approximately 24 months

Number of Patients with Clinically Significant Laboratory Abnormalities

Timeframe: Approximately 24 months

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

Timeframe: Baseline up to 15 days

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

Timeframe: Baseline up to 15 days

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

Timeframe: Baseline up to 15 days