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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05215574
Recruitment Status : Recruiting
First Posted : January 31, 2022
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
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 Drug: NGM831 Drug: NGM831 plus pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Experimental: NGM831 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
Drug: NGM831
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

Experimental: NGM831 Combination Dose Finding with Pembrolizumab
Part 1b NGM831 plus pembrolizumab
Drug: NGM831 plus pembrolizumab

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

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


Experimental: NGM831 Monotherapy Dose Expansion
Part 2a Single Agent Dose Expansion
Drug: NGM831
Drug: NGM831 Preliminary recommended phase 2 dose (RP2D) of NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle.




Primary Outcome Measures :
  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 adverse events (AEs) according to severity, seriousness, and relationship to study drug.

    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.


  3. Number of Patients with Clinically Significant Laboratory Abnormalities [ Time Frame: Baseline up to Approximately 24 months ]
    Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of NGM831 [ Time Frame: Baseline up to approximately 24 months ]

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

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter


  2. Area Under the Curve (AUC) of Serum NGM831 [ Time Frame: Baseline up to approximately 24 months ]

    Area under the curve from time zero extrapolated to the last time point prior to the next dose.

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.


  3. Time to Maximum (Tmax) Observed Serum Concentration of NGM831 [ Time Frame: Baseline up to approximately 24 months ]

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

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.


  4. Half-life (t1/2) of NGM831 in Serum [ Time Frame: Baseline up to approximately 24 months ]

    Time measured for the serum concentration to decrease by one half during the terminal phase.

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.


  5. Systemic Clearance (CL) of NGM831 [ Time Frame: Baseline up to approximately 24 months ]

    CL is defined as systemic clearance.

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.


  6. Volume of Distribution (Vss) of NGM831 at Steady State [ Time Frame: Baseline up to approximately 24 months ]

    Vss is defined as the volume of distribution at steady state.

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.


  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. Number of Patients in Expansion Cohort 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

  9. Trough Concentrations of NGM831 [ Time Frame: Baseline up to approximately 24 months ]

    Trough Concentration refers to the serum concentration of NGM831 observed just before treatment administration.

    Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05215574


Contacts
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Contact: NGM Medical Director (650) 243-5555 NGM831@ngmbio.com

Locations
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United States, Arizona
Banner MD Anderson Medical Center Recruiting
Gilbert, Arizona, United States, 85234
United States, California
The Angeles Clinic Recruiting
Los Angeles, California, United States, 90025
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
Next Oncology Recruiting
Austin, Texas, United States, 78758
The University of Texas - MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Merck Sharp & Dohme LLC
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT05215574    
Other Study ID Numbers: 831-IO-101
KEYNOTE-E13 ( Other Identifier: Alias Study Number )
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Mesothelioma
Cholangiocarcinoma
Colorectal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Adenocarcinoma
Head and Neck Neoplasms
Adenoma
Neoplasms, Mesothelial
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents