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

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

NGM Biopharmaceuticals, Inc

Tracking Information

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Serum Concentration of NGM120 [ Time Frame: 19 weeks ]
NGM120 concentration data by cohort.
Assessment of Anticancer Activity [ Time Frame: 19 weeks ]
Assessed using the RECIST Version 1.1 criteria

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

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Cancer
Metastatic Castration-resistant Prostate Cancer
Bladder Cancer
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
Gastric Cancer
Esophageal Cancer
Ovarian Cancer
Head Neck Squamous Cell Carcinoma

Intervention ^ICMJE

Biological: NGM120
NGM120 Dose 1
Biological: NGM120
NGM120 Dose 2
Biological: NGM120
NGM120 Dose 3
Biological: NGM120
NGM120 Dose 4
Biological: NGM120
NGM120 Dose 5
Biological: NGM120
NGM120 Dose 6
Other: Placebo
Placebo

Study Arms ^ICMJE

Experimental: NGM120 Dose 1
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Experimental: NGM120 Dose 2
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Experimental: NGM120 Dose 3
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Experimental: NGM120 Dose 4
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Experimental: NGM120 Dose 5
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Experimental: NGM120 Dose 6
NGM120 Subcutaneous Injection

Intervention: Biological: NGM120
Placebo Comparator: Placebo
Placebo

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

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:

Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
Have not received any approved chemotherapy, except in the adjuvant setting.

Exclusion Criteria:

Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication.
Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
Subject has documented immunodeficiency or organ transplant.
Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure > New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation >470 msec, clinically significant pericardial effusion.
Subject has a history or presence of documented inflammatory bowel disease.
Subject is known to be positive for human immunodeficiency virus infection.

-

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: NGM Study Director

650-243-5555

ngm120@ngmbio.com

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

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

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

Study Director:

NGM Study Director

NGM Biopharmaceuticals, Inc

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

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