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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04913337
• Other study ID #: 707-IO-101
• Secondary ID: KEYNOTE-D25MK-34
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 9, 2021
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Cervical Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Glioblastoma
• Melanoma
• Mesothelioma
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Ductal Adenocarcinoma
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	NGM Clinical Study Site	Seoul
Korea, Republic of	NGM Clinical Study Site	Seoul
Korea, Republic of	NGM Clinical Study Site	Seoul
Taiwan	NGM Clinical Study Site	New Taipei City
Taiwan	NGM Clinical Study Site	Taichung
Taiwan	NGM Clinical Study Site	Tainan
Taiwan	NGM Clinical Study Site	Taipei
United States	NGM Clinical Study Site	Albany	New York
United States	NGM Clinical Study Site	Baltimore	Maryland
United States	NGM Clinical Study Site	Blacksburg	Virginia
United States	NGM Clinical Study Site	Boston	Massachusetts
United States	NGM Clinical Study Site	Dallas	Texas
United States	NGM Clinical Study Site	Dallas	Texas
United States	NGM Clinical Study Site	Grand Rapids	Michigan
United States	NGM Clinical Study Site	Greenville	South Carolina
United States	NGM Clinical Study Site	Houston	Texas
United States	NGM Clinical Study Site	Lone Tree	Colorado
United States	NGM Clinical Study Site	Los Angeles	California
United States	NGM Clinical Study Site	Newport Beach	California
United States	NGM Clinical Study Site	Omaha	Nebraska
United States	NGM Clinical Study Site	San Antonio	Texas
United States	NGM Clinical Study Site	San Antonio	Texas
United States	NGM Clinical Study Site	Santa Monica	California
United States	NGM Clinical Study Site	Santa Rosa	California
United States	NGM Clinical Study Site	Sarasota	Florida
United States	NGM Clinical Study Site	Vancouver	Washington
United States	NGM Clinical Study Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 28 Days
Primary	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.	Baseline up to Approximately 24 Months
Primary	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.	Baseline up to Approximately 24 Months
Primary	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	Baseline up to approximately 24 months
Primary	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.	Baseline up to approximately 24 months
Primary	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.	Baseline up to approximately 24 months
Primary	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.	Up to approximately 48 months
Secondary	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.	Baseline up to approximately 24 months
Secondary	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.	Baseline up to approximately 24 months
Secondary	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.	Baseline up to approximately 24 months
Secondary	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.	Baseline up to approximately 24 months