Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

NCT04913337 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 707-IO-101KEYNOTE-D25MK-3475-D25
• Study Type: interventional
• Target: 179
• Locations: 3 countries
• Sites: 27

Brief Summary

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Conditions

Mesothelioma; Glioblastoma; Renal Cell Carcinoma; Non Small Cell Lung Cancer; Melanoma; Pancreatic Ductal Adenocarcinoma; Gastric Cancer; Squamous Cell Carcinoma of Head and Neck; Cholangiocarcinoma; Breast Cancer; Ovarian Cancer; Cervical Cancer; Endocervical Cancer; Colorectal Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (7)

• Number of Patients with Dose-limiting Toxicities

  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 28 days after the first dose of study treatment.

  Baseline up to 28 Days

• Incidence of Adverse Events

  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.

  Baseline up to Approximately 24 Months

• Number of Patients with Clinically Significant Laboratory Abnormalities

  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.

  Baseline up to Approximately 24 Months

• Number of Patients in Expansion Cohorts with Objective Responses

  Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1

  Baseline up to approximately 24 months

• Duration of Response for Patients in Expansion Cohorts

  Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

  Baseline up to approximately 24 months

• Progression-free Survival for Patients in Expansion Cohorts

  Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.

  Baseline up to approximately 24 months

• Overall Survival for Patients in Combination Dose Expansion Cohorts

  Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.

  Up to approximately 48 months

Secondary Outcomes (4)

• Observed Plasma Concentration of NGM707 (Including Cmax)

  Baseline up to approximately 24 months

• Area Under the Curve (AUC) of Plasma NGM707

  Baseline up to approximately 24 months

• Plasma Half-life (t1/2) of NGM707

  Baseline up to approximately 24 months

• Anti-drug Antibodies (ADA) Against NGM707

  Baseline up to approximately 24 months

Study Arms (8)

NGM707 Monotherapy Dose Escalation

EXPERIMENTAL

Part 1a Single Agent Dose Escalation

Drug: NGM707

NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®)

EXPERIMENTAL

Part 1b NGM707 plus pembrolizumab (KEYTRUDA®)

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm A

EXPERIMENTAL

NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm B

EXPERIMENTAL

NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Combination Dose Expansion Arm C

EXPERIMENTAL

NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN

Drug: NGM707 plus pembrolizumab (KEYTRUDA®)

NGM707 Monotherapy Dose Expansion Arm D

EXPERIMENTAL

NGM707 in RCC

Drug: NGM707

NGM707 Monotherapy Dose Expansion Arm E

EXPERIMENTAL

NGM707 in CRC

Drug: NGM707

NGM707 Monotherapy Dose Expansion Arm F

EXPERIMENTAL

NGM707 in Ovarian

Drug: NGM707

Interventions

NGM707 DRUG

Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

NGM707 Monotherapy Dose Escalation

NGM707 plus pembrolizumab (KEYTRUDA®) DRUG

Drug: NGM707 NGM707 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.

NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (27)

NGM Clinical Study Site

Los Angeles, California, 90033, United States

Location

NGM Clinical Study Site

Newport Beach, California, 92663, United States

Location

NGM Clinical Study Site

Santa Monica, California, 90404, United States

Location

NGM Clinical Study Site

Santa Rosa, California, 94505, United States

Location

NGM Clinical Study Site

Lone Tree, Colorado, 80124, United States

Location

NGM Clinical Study Site

Washington D.C., District of Columbia, 20007, United States

Location

NGM Clinical Study Site

Sarasota, Florida, 34232, United States

Location

NGM Clinical Study Site

Baltimore, Maryland, 21201, United States

Location

NGM Clinical Study Site

Boston, Massachusetts, 02215, United States

Location

NGM Clinical Study Site

Grand Rapids, Michigan, 49546, United States

Location

NGM Clinical Study Site

Omaha, Nebraska, 68130, United States

Location

NGM Clinical Study Site

Albany, New York, 12206, United States

Location

NGM Clinical Study Site

Greenville, South Carolina, 29605, United States

Location

NGM Clinical Study Site

Dallas, Texas, 75246, United States

Location

NGM Clinical Study Site

Dallas, Texas, 78701, United States

Location

NGM Clinical Study Site

Houston, Texas, 77030, United States

Location

NGM Clinical Study Site

San Antonio, Texas, 78229, United States

Location

NGM Clinical Study Site

San Antonio, Texas, 78240, United States

Location

NGM Clinical Study Site

Blacksburg, Virginia, 24060, United States

Location

NGM Clinical Study Site

Vancouver, Washington, 98684, United States

Location

NGM Clinical Study Site

Seoul, 03080, South Korea

Location

NGM Clinical Study Site

Seoul, 05505, South Korea

Location

NGM Clinical Study Site

Seoul, 06351, South Korea

Location

NGM Clinical Study Site

New Taipei City, 235, Taiwan

Location

NGM Clinical Study Site

Taichung, 404327, Taiwan

Location

NGM Clinical Study Site

Tainan, 704, Taiwan

Location

NGM Clinical Study Site

Taipei, 100225, Taiwan

Location

MeSH Terms

Conditions

Mesothelioma; Glioblastoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Melanoma; Stomach Neoplasms; Squamous Cell Carcinoma of Head and Neck; Cholangiocarcinoma; Breast Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Breast Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Esophageal Diseases

Study Officials

• Chief Medical Officer

  NGM Biopharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 4, 2021
• Study Start: June 9, 2021
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-06

Locations

KR (3); US (20); TW (4)