Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
NCT ID: NCT04913337
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
179 participants
INTERVENTIONAL
2021-06-09
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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NGM707 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®)
Part 1b NGM707 plus pembrolizumab (KEYTRUDA®)
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.
NGM707 Combination Dose Expansion Arm A
NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC
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.
NGM707 Combination Dose Expansion Arm B
NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC
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.
NGM707 Combination Dose Expansion Arm C
NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN
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.
NGM707 Monotherapy Dose Expansion Arm D
NGM707 in RCC
NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707 Monotherapy Dose Expansion Arm E
NGM707 in CRC
NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707 Monotherapy Dose Expansion Arm F
NGM707 in Ovarian
NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Interventions
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NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
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.
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.
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.
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.
NGM707
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.
NGM707
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals, Inc
Locations
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NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Newport Beach, California, United States
NGM Clinical Study Site
Santa Monica, California, United States
NGM Clinical Study Site
Santa Rosa, California, United States
NGM Clinical Study Site
Lone Tree, Colorado, United States
NGM Clinical Study Site
Washington D.C., District of Columbia, United States
NGM Clinical Study Site
Sarasota, Florida, United States
NGM Clinical Study Site
Baltimore, Maryland, United States
NGM Clinical Study Site
Boston, Massachusetts, United States
NGM Clinical Study Site
Grand Rapids, Michigan, United States
NGM Clinical Study Site
Omaha, Nebraska, United States
NGM Clinical Study Site
Albany, New York, United States
NGM Clinical Study Site
Greenville, South Carolina, United States
NGM Clinical Study Site
Dallas, Texas, United States
NGM Clinical Study Site
Dallas, Texas, United States
NGM Clinical Study Site
Houston, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
Blacksburg, Virginia, United States
NGM Clinical Study Site
Vancouver, Washington, United States
NGM Clinical Study Site
Seoul, , South Korea
NGM Clinical Study Site
Seoul, , South Korea
NGM Clinical Study Site
Seoul, , South Korea
NGM Clinical Study Site
New Taipei City, , Taiwan
NGM Clinical Study Site
Taichung, , Taiwan
NGM Clinical Study Site
Tainan City, , Taiwan
NGM Clinical Study Site
Taipei, , Taiwan
Countries
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Other Identifiers
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KEYNOTE-D25
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-D25
Identifier Type: OTHER
Identifier Source: secondary_id
707-IO-101
Identifier Type: -
Identifier Source: org_study_id
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