Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Glioblastoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Mesothelioma

Mesothelioma, Malignant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Head and Neck Neoplasms

Adenoma

Neoplasms, Mesothelial

Esophageal Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Drug: NGM707

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

NGM707

Drug: NGM707

NGM707 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.

NGM707 plus pembrolizumab

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: pembrolizumab

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

NGM Medical Director

NGM Site 004

NGM Site 016

NGM Site 010

NGM Site 008

NGM Site 009

NGM Site 007

NGM Site 014

NGM Site 003

NGM Site 012

NGM Site 013

NGM Site 006

NGM Site 001

NGM Site 002

NGM Site 200

NGM Site 201

NGM Site 252

NGM Site 250

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

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

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

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.

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.

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.

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

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.

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.

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

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.

Area under the curve from time zero extrapolated to the last quantifiable dose of NGM707. Time zero extrapolated to the last quantifiable 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.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. 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.

Incidence and titers of anti-drug antibodies (ADA) against NGM707. Will be measured on Day 1 of each cycle.

Merck Sharp & Dohme LLC

NGM Biopharmaceuticals, Inc

Spots Global Cancer Trial Database for ngm707 plus pembrolizumab