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

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ClinicalTrials.gov Identifier: NCT04913337
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
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 Drug: NGM707 Drug: NGM707 plus pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 179 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : July 2025


Arm Intervention/treatment
Experimental: NGM707 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
Drug: NGM707

Drug: NGM707

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


Experimental: NGM707 Combination Dose Finding with pembrolizumab
Part 1b NGM707 plus pembrolizumab
Drug: NGM707 plus pembrolizumab

Drug: NGM707

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

Drug: pembrolizumab

Pembrolizumab will be administered intravenously (IV) on Day 1 of each 21 day cycle.


Experimental: NGM707 Monotherapy Dose Expansion Arm A
NGM707 in RCC
Drug: NGM707

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.


Experimental: NGM707 Monotherapy Dose Expansion Arm B
NGM707 in CRC
Drug: NGM707

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.


Experimental: NGM707 Monotherapy Dose Expansion Arm C
NGM707 in Ovarian Cancer
Drug: NGM707

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.


Experimental: NGM707 Combination Dose Expansion Arm E
NGM707 with pembrolizumab in NSCLC
Drug: NGM707 plus pembrolizumab

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: pembrolizumab

Pembrolizumab will be administered intravenously (IV) on Day 1 of each 21 day cycle.


Experimental: NGM707 Combination Dose Expansion Arm F
NGM707 with pembrolizumab in SCCHN
Drug: NGM707 plus pembrolizumab

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: pembrolizumab

Pembrolizumab will be administered intravenously (IV) on Day 1 of each 21 day cycle.





Primary Outcome Measures :
  1. Number of Patients with Dose-limiting Toxicities [ Time Frame: Baseline up to 28 Days ]
    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.

  2. Incidence of Adverse Events [ Time Frame: Baseline up to Approximately 24 Months ]

    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.


  3. Number of Patients with Clinically Significant Laboratory Abnormalities [ Time Frame: Baseline up to Approximately 24 Months ]
    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.

  4. Number of Patients in Expansion Cohorts with Objective Responses [ Time Frame: Baseline up to approximately 24 months ]
    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

  5. Duration of Response for Patients in Expansion Cohorts [ Time Frame: Baseline up to approximately 24 months ]
    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.

  6. Progression-free Survival for Patients in Expansion Cohorts [ Time Frame: Baseline up to approximately 24 months ]
    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.

  7. Overall Survival for Patients in Expansion Cohorts of Part 2b [ Time Frame: Up to approximately 48 months ]
    Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.


Secondary Outcome Measures :
  1. Observed Plasma Concentration of NGM707 (Including Cmax) [ Time Frame: Baseline up to approximately 24 months ]
    NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter.

  2. Area Under the Curve (AUC) of Plasma NGM707 [ Time Frame: Baseline up to approximately 24 months ]
    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. NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter.

  3. Plasma Half-life (t1/2) of NGM707 [ Time Frame: Baseline up to approximately 24 months ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NGM707 will be measured at the end of infusion on Cycle 1 Day 1 and on days 2, 4, 8, and 15 of Cycle 1; pre-dose and end of infusion on Day 1 of Cycle 2, and every cycle thereafter.

  4. Anti-drug Antibodies (ADA) Against NGM707 [ Time Frame: Baseline up to approximately 24 months ]
    Incidence and titers of anti-drug antibodies (ADA) against NGM707. NGM707 will be measured pre-dose on Day 1 of Cycle 1, and every cycle thereafter.

  5. Neutralizing Antibodies (NAb) Against NGM707 [ Time Frame: Baseline up to approximately 24 months ]
    Incidence and titers of neutralizing antibodies (NAb) against NGM707. NGM707 will be measured pre-dose on Day 1 of Cycle 1, and every cycle thereafter.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913337


Contacts
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Contact: NGM Medical Director (650) 243-5555 NGM707@ngmbio.com

Locations
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United States, Michigan
START Midwest, LLC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: NGM Site 003         
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: NGM Site 002         
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04913337    
Other Study ID Numbers: 707-IO-101
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Head and Neck Neoplasms
Neoplasms, Mesothelial
Carcinoma
Glioblastoma
Mesothelioma
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Adenocarcinoma
Astrocytoma
Glioma
Adenoma
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents