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Active, Not Recruiting

NCT Number: NCT05215574

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Cancer Adenocarcinoma Adenoma Adnexal Diseases Bladder Urothelial Cancer Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Cervical Cancer Cholangiocarcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocervical Cancer Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site, Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NGM831

Drug

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

NGM831 plus pembrolizumab (KEYTRUDA®)

Drug

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated.

Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle.

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Drug

Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated.

Drug: NGM438 NGM438 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.

Primary outcomes

  1. Number of Patients with Dose-limiting Toxicities

    Time frame: Baseline up to 21 Days

    A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.

  2. Incidence of Adverse Events

    Time frame: Baseline up to Approximately 24 months

    Number of patients with treatment-emergent adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of NGM831

    Time frame: Baseline up to approximately 9 weeks

    Cmax is defined as the observed maximum serum concentration post drug administration.

    Will be measured for Cycle 1 and Cycle 3.

  2. Time to Maximum Observed Serum Concentration (Tmax) of NGM831

    Time frame: Baseline up to approximately 9 weeks

    Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration.

    Will be measured for Cycle 1 and Cycle 3.

  3. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831

    Time frame: Baseline up to approximately 9 weeks

    AUC is defined as area under the concentration time curve of the dosing interval post drug administration.

    Will be calculated for Cycle 1 and Cycle 3.

  4. Maximum Observed Serum Concentration (Cmax) of NGM438

    Time frame: Baseline up to approximately 9 weeks

    Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3.

  5. Time to Maximum Observed Serum Concentration (Tmax) of NGM438.

    Time frame: Baseline up to approximately 9 weeks

    Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration.

    Will be measured for Cycle 1 and Cycle 3.

  6. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438

    Time frame: Baseline up to approximately 9 weeks

    AUC is defined as area under the concentration time curve of the dosing interval post drug administration.

    Will be calculated for Cycle 1 and Cycle 3.

  7. Anti-drug Antibodies (ADA) Against NGM831

    Time frame: Baseline up to approximately 24 months

    Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle.

  8. Anti-drug Antibodies (ADA) Against NGM438

    Time frame: Baseline up to approximately 24 months

    Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle.

  9. Neutralizing antibodies (nAb) against NGM831

    Time frame: Baseline up to approximately 24 months

    Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.

  10. Neutralizing antibodies (nAb) against NGM438

    Time frame: Baseline up to approximately 24 months

    Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.

  11. Number of Patients with Objective Responses

    Time frame: Baseline up to approximately 24 months

    Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) divided by the total number of evaluable patients per RECIST v1.1.

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2022
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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