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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 South Korea, 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 5368361, California 5332921

Status

Address

NGM Clinical Study Site

Los Angeles 5368361, California 5332921, 90033

NGM Clinical Study Site, Newport Beach 5376890, California 5332921

Status

Address

NGM Clinical Study Site

Newport Beach 5376890, California 5332921, 92663

NGM Clinical Study Site, Santa Monica 5393212, California 5332921

Status

Address

NGM Clinical Study Site

Santa Monica 5393212, California 5332921, 90404

NGM Clinical Study Site, Santa Rosa 5393287, California 5332921

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Address

NGM Clinical Study Site

Santa Rosa 5393287, California 5332921, 94505

NGM Clinical Study Site, Lone Tree 5429208, Colorado 5417618

Status

Address

NGM Clinical Study Site

Lone Tree 5429208, Colorado 5417618, 80124

NGM Clinical Study Site, Washington D.C. 4140963, District of Columbia 4138106

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Address

NGM Clinical Study Site

Washington D.C. 4140963, District of Columbia 4138106, 20007

NGM Clinical Study Site, Sarasota 4172131, Florida 4155751

Status

Address

NGM Clinical Study Site

Sarasota 4172131, Florida 4155751, 34232

NGM Clinical Study Site, Baltimore 4347778, Maryland 4361885

Status

Address

NGM Clinical Study Site

Baltimore 4347778, Maryland 4361885, 21201

NGM Clinical Study Site, Boston 4930956, Massachusetts 6254926

Status

Address

NGM Clinical Study Site

Boston 4930956, Massachusetts 6254926, 02215

NGM Clinical Study Site, Grand Rapids 4994358, Michigan 5001836

Status

Address

NGM Clinical Study Site

Grand Rapids 4994358, Michigan 5001836, 49546

NGM Clinical Study Site, Omaha 5074472, Nebraska 5073708

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Address

NGM Clinical Study Site

Omaha 5074472, Nebraska 5073708, 68130

NGM Clinical Study Site, Albany 5106834, New York 5128638

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Address

NGM Clinical Study Site

Albany 5106834, New York 5128638, 12206

NGM Clinical Study Site, Greenville 4580543, South Carolina 4597040

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Address

NGM Clinical Study Site

Greenville 4580543, South Carolina 4597040, 29605

NGM Clinical Study Site, Dallas 4684888, Texas 4736286

Status

Address

NGM Clinical Study Site

Dallas 4684888, Texas 4736286, 75246

NGM Clinical Study Site, Dallas 4684888, Texas 4736286

Status

Address

NGM Clinical Study Site

Dallas 4684888, Texas 4736286, 78701

NGM Clinical Study Site, Houston 4699066, Texas 4736286

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Address

NGM Clinical Study Site

Houston 4699066, Texas 4736286, 77030

NGM Clinical Study Site, San Antonio 4726206, Texas 4736286

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Address

NGM Clinical Study Site

San Antonio 4726206, Texas 4736286, 78229

NGM Clinical Study Site, San Antonio 4726206, Texas 4736286

Status

Address

NGM Clinical Study Site

San Antonio 4726206, Texas 4736286, 78240

NGM Clinical Study Site, Blacksburg 4747845, Virginia 6254928

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Address

NGM Clinical Study Site

Blacksburg 4747845, Virginia 6254928, 24060

NGM Clinical Study Site, Vancouver 5814616, Washington 5815135

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Address

NGM Clinical Study Site

Vancouver 5814616, Washington 5815135, 98684

International Sites

NGM Clinical Study Site, Seoul 1835848, South Korea

Status

Address

NGM Clinical Study Site

Seoul 1835848, , 03080

NGM Clinical Study Site, Seoul 1835848, South Korea

Status

Address

NGM Clinical Study Site

Seoul 1835848, , 05505

NGM Clinical Study Site, Seoul 1835848, South Korea

Status

Address

NGM Clinical Study Site

Seoul 1835848, , 06351

NGM Clinical Study Site, New Taipei City 12908892, Taiwan

Status

Address

NGM Clinical Study Site

New Taipei City 12908892, , 235

NGM Clinical Study Site, Taichung 1668399, Taiwan

Status

Address

NGM Clinical Study Site

Taichung 1668399, , 404327

NGM Clinical Study Site, Tainan City 1668355, Taiwan

Status

Address

NGM Clinical Study Site

Tainan City 1668355, , 704

NGM Clinical Study Site, Taipei 1668341, Taiwan

Status

Address

NGM Clinical Study Site

Taipei 1668341, , 100225