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

Status: Active_not_recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
NGM Clinical Study Site
Los Angeles
NGM Clinical Study Site
Newport Beach
NGM Clinical Study Site
Santa Monica
NGM Clinical Study Site
Santa Rosa
Colorado
NGM Clinical Study Site
Lone Tree
Washington, D.c.
NGM Clinical Study Site
Washington D.c.
Florida
NGM Clinical Study Site
Sarasota
Massachusetts
NGM Clinical Study Site
Boston
Maryland
NGM Clinical Study Site
Baltimore
Michigan
NGM Clinical Study Site
Grand Rapids
Nebraska
NGM Clinical Study Site
Omaha
New York
NGM Clinical Study Site
Albany
South Carolina
NGM Clinical Study Site
Greenville
Texas
NGM Clinical Study Site
Dallas
NGM Clinical Study Site
Dallas
NGM Clinical Study Site
Houston
NGM Clinical Study Site
San Antonio
NGM Clinical Study Site
San Antonio
Virginia
NGM Clinical Study Site
Blacksburg
Washington
NGM Clinical Study Site
Vancouver
Other Locations
Republic of Korea
NGM Clinical Study Site
Seoul
NGM Clinical Study Site
Seoul
NGM Clinical Study Site
Seoul
Taiwan
NGM Clinical Study Site
New Taipei City
NGM Clinical Study Site
Taichung
NGM Clinical Study Site
Tainan
NGM Clinical Study Site
Taipei
Time Frame
Start Date: 2021-06-09
Completion Date: 2025-07
Participants
Target number of participants: 179
Treatments
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
Sponsors
Leads: NGM Biopharmaceuticals, Inc
Collaborators: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov