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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

NGM707

NGM707 plus pembrolizumab

NGM707

NGM707 plus pembrolizumab

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 ILT2 and/or ILT4 or targeting HLA-G.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

NGM707 Monotherapy Dose Escalation

NGM707 Combination Dose Finding with pembrolizumab

NGM707 Monotherapy Dose Expansion Arm A

NGM707 Monotherapy Dose Expansion Arm B

NGM707 Monotherapy Dose Expansion Arm C

NGM707 Combination Dose Expansion Arm E

NGM707 Combination Dose Expansion Arm F

Arm Description

Part 1a Single Agent Dose Escalation

Part 1b NGM707 plus pembrolizumab

NGM707 in RCC

NGM707 in CRC

NGM707 in Ovarian Cancer

NGM707 with pembrolizumab in NSCLC

NGM707 with pembrolizumab in SCCHN

Outcomes

Primary Outcome Measures

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.

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.

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.

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

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.

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.

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.

Secondary Outcome Measures

Observed Plasma Concentration of NGM707 (Including 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.

Area Under the Curve (AUC) of Plasma NGM707

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 Half-life (t1/2) of NGM707

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.

Anti-drug Antibodies (ADA) Against NGM707

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

Full Information

NCT ID

NCT04913337

First Posted

May 20, 2021

Last Updated

February 8, 2023

Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04913337

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 9, 2021 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

179 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NGM707 Monotherapy Dose Escalation

Arm Type

Experimental

Arm Description

Part 1a Single Agent Dose Escalation

Arm Title

NGM707 Combination Dose Finding with pembrolizumab

Arm Type

Experimental

Arm Description

Part 1b NGM707 plus pembrolizumab

Arm Title

NGM707 Monotherapy Dose Expansion Arm A

Arm Type

Experimental

Arm Description

NGM707 in RCC

Arm Title

NGM707 Monotherapy Dose Expansion Arm B

Arm Type

Experimental

Arm Description

NGM707 in CRC

Arm Title

NGM707 Monotherapy Dose Expansion Arm C

Arm Type

Experimental

Arm Description

NGM707 in Ovarian Cancer

Arm Title

NGM707 Combination Dose Expansion Arm E

Arm Type

Experimental

Arm Description

NGM707 with pembrolizumab in NSCLC

Arm Title

NGM707 Combination Dose Expansion Arm F

Arm Type

Experimental

Arm Description

NGM707 with pembrolizumab in SCCHN

Intervention Type

Drug

Intervention Name(s)

NGM707

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NGM707 plus pembrolizumab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NGM707

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NGM707

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NGM707

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NGM707 plus pembrolizumab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NGM707 plus pembrolizumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients with Dose-limiting Toxicities

Description

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.

Time Frame

Baseline up to 28 Days

Title

Incidence of Adverse Events

Description

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.

Time Frame

Baseline up to Approximately 24 Months

Title

Number of Patients with Clinically Significant Laboratory Abnormalities

Description

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.

Time Frame

Baseline up to Approximately 24 Months

Title

Number of Patients in Expansion Cohorts with Objective Responses

Description

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

Time Frame

Baseline up to approximately 24 months

Title

Duration of Response for Patients in Expansion Cohorts

Description

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.

Time Frame

Baseline up to approximately 24 months

Title

Progression-free Survival for Patients in Expansion Cohorts

Description

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.

Time Frame

Baseline up to approximately 24 months

Title

Overall Survival for Patients in Combination Dose Expansion Cohorts

Description

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

Time Frame

Up to approximately 48 months

Secondary Outcome Measure Information:

Title

Observed Plasma Concentration of NGM707 (Including Cmax)

Description

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.

Time Frame

Baseline up to approximately 24 months

Title

Area Under the Curve (AUC) of Plasma NGM707

Description

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.

Time Frame

Baseline up to approximately 24 months

Title

Plasma Half-life (t1/2) of NGM707

Description

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.

Time Frame

Baseline up to approximately 24 months

Title

Anti-drug Antibodies (ADA) Against NGM707

Description

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

Time Frame

Baseline up to approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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 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 ILT2 and/or ILT4 or targeting HLA-G.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

NGM Medical Director

Phone

(650) 243-5555

Email

NGM707@ngmbio.com

Facility Information:

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 004

Facility Name

Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 016

Facility Name

UCLA Medical Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 010

Facility Name

Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 008

Facility Name

Florida Cancer Specialists - Sarasota - SCRI

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 009

Facility Name

University of Maryland Greenebaum Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 007

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 014

Facility Name

START Midwest, LLC

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 003

Facility Name

Nebraska Cancer Specialists

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 012

Facility Name

Prisma Health - Upstate

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 013

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

78701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 006

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 001

Facility Name

NEXT Oncology

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 002

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 200

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 201

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

404327

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 252

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100225

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NGM Site 250

Mesothelioma, Glioblastoma, Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial