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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04913337
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NGM Biopharmaceuticals, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chief Medical Officer
Principal Investigator Affiliation NGM Biopharmaceuticals, Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Korea, Republic of, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Arms & Interventions

Arms

Experimental: NGM707 Monotherapy Dose Escalation

Part 1a Single Agent Dose Escalation

Experimental: NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®)

Part 1b NGM707 plus pembrolizumab (KEYTRUDA®)

Experimental: NGM707 Combination Dose Expansion Arm A

NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC

Experimental: NGM707 Combination Dose Expansion Arm B

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

Experimental: NGM707 Combination Dose Expansion Arm C

NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN

Experimental: NGM707 Monotherapy Dose Expansion Arm D

NGM707 in RCC

Experimental: NGM707 Monotherapy Dose Expansion Arm E

NGM707 in CRC

Experimental: NGM707 Monotherapy Dose Expansion Arm F

NGM707 in Ovarian

Interventions

Drug: - NGM707

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

Drug: - NGM707 plus pembrolizumab (KEYTRUDA®)

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.

Drug: - NGM707 plus pembrolizumab (KEYTRUDA®)

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.

Drug: - NGM707 plus pembrolizumab (KEYTRUDA®)

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.

Drug: - NGM707 plus pembrolizumab (KEYTRUDA®)

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.

Drug: - NGM707

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

Drug: - NGM707

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

Drug: - NGM707

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NGM Clinical Study Site, Los Angeles, California

Status

Address

NGM Clinical Study Site

Los Angeles, California, 90033

NGM Clinical Study Site, Newport Beach, California

Status

Address

NGM Clinical Study Site

Newport Beach, California, 92663

NGM Clinical Study Site, Santa Monica', California

Status

Address

NGM Clinical Study Site

Santa Monica', California, 90404

NGM Clinical Study Site, Santa Rosa, California

Status

Address

NGM Clinical Study Site

Santa Rosa, California, 94505

NGM Clinical Study Site, Lone Tree, Colorado

Status

Address

NGM Clinical Study Site

Lone Tree, Colorado, 80124

NGM Clinical Study Site, Washington, District of Columbia

Status

Address

NGM Clinical Study Site

Washington, District of Columbia, 20007

NGM Clinical Study Site, Sarasota, Florida

Status

Address

NGM Clinical Study Site

Sarasota, Florida, 34232

NGM Clinical Study Site, Baltimore, Maryland

Status

Address

NGM Clinical Study Site

Baltimore, Maryland, 21201

NGM Clinical Study Site, Boston, Massachusetts

Status

Address

NGM Clinical Study Site

Boston, Massachusetts, 02215

NGM Clinical Study Site, Grand Rapids, Michigan

Status

Address

NGM Clinical Study Site

Grand Rapids, Michigan, 49546

NGM Clinical Study Site, Omaha, Nebraska

Status

Address

NGM Clinical Study Site

Omaha, Nebraska, 68130

NGM Clinical Study Site, Albany, New York

Status

Address

NGM Clinical Study Site

Albany, New York, 12206

NGM Clinical Study Site, Greenville, South Carolina

Status

Address

NGM Clinical Study Site

Greenville, South Carolina, 29605

NGM Clinical Study Site, Dallas, Texas

Status

Address

NGM Clinical Study Site

Dallas, Texas, 75246

NGM Clinical Study Site, Dallas, Texas

Status

Address

NGM Clinical Study Site

Dallas, Texas, 78701

NGM Clinical Study Site, Houston, Texas

Status

Address

NGM Clinical Study Site

Houston, Texas, 77030

NGM Clinical Study Site, San Antonio, Texas

Status

Address

NGM Clinical Study Site

San Antonio, Texas, 78229

NGM Clinical Study Site, San Antonio, Texas

Status

Address

NGM Clinical Study Site

San Antonio, Texas, 78240

NGM Clinical Study Site, Blacksburg, Virginia

Status

Address

NGM Clinical Study Site

Blacksburg, Virginia, 24060

NGM Clinical Study Site, Vancouver, Washington

Status

Address

NGM Clinical Study Site

Vancouver, Washington, 98684

International Sites

NGM Clinical Study Site, Seoul, Korea, Republic of

Status

Address

NGM Clinical Study Site

Seoul, , 03080

NGM Clinical Study Site, Seoul, Korea, Republic of

Status

Address

NGM Clinical Study Site

Seoul, , 05505

NGM Clinical Study Site, Seoul, Korea, Republic of

Status

Address

NGM Clinical Study Site

Seoul, , 06351

NGM Clinical Study Site, New Taipei City, Taiwan

Status

Address

NGM Clinical Study Site

New Taipei City, , 235

NGM Clinical Study Site, Taichung, Taiwan

Status

Address

NGM Clinical Study Site

Taichung, , 404327

NGM Clinical Study Site, Tainan, Taiwan

Status

Address

NGM Clinical Study Site

Tainan, , 704

NGM Clinical Study Site, Taipei, Taiwan

Status

Address

NGM Clinical Study Site

Taipei, , 100225