Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (PINNACLES)
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ClinicalTrials.gov Identifier: NCT04068896 |
Recruitment Status :
Recruiting
First Posted : August 28, 2019
Last Update Posted : March 2, 2022
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Sponsor:
NGM Biopharmaceuticals, Inc
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc
Tracking Information | |||||
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First Submitted Date ICMJE | August 22, 2019 | ||||
First Posted Date ICMJE | August 28, 2019 | ||||
Last Update Posted Date | March 2, 2022 | ||||
Actual Study Start Date ICMJE | October 16, 2019 | ||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 19 weeks ] The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy | ||||
Official Title ICMJE | A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy | ||||
Brief Summary | Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
75 | ||||
Original Estimated Enrollment ICMJE |
90 | ||||
Estimated Study Completion Date ICMJE | January 2025 | ||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04068896 | ||||
Other Study ID Numbers ICMJE | 18-0402 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | NGM Biopharmaceuticals, Inc | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | NGM Biopharmaceuticals, Inc | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | NGM Biopharmaceuticals, Inc | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |