Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

• ClinicalTrials.gov Identifier: NCT04068896
• Recruitment Status: Recruiting
• First Posted: August 28, 2019
• Last Update Posted: April 26, 2021
• Sponsor: NGM Biopharmaceuticals, Inc
• Information provided by (Responsible Party): NGM Biopharmaceuticals, Inc

Tracking Information

• First Submitted Date: August 22, 2019
• First Posted Date: August 28, 2019
• Last Update Posted Date: April 26, 2021
• Actual Study Start Date: October 16, 2019
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2019)

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: Same as current

Current Secondary Outcome Measures (submitted: August 23, 2019)

• 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• 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

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 23, 2019): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2023
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Have histologically confirmed advanced or metastatic castration-resistant prostate cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck squamous cell carcinoma.

   Or,

   Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.

2. Have not received any approved chemotherapy, except in the adjuvant setting.

Exclusion Criteria:

1. 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.
2. Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
4. Subject has documented immunodeficiency or organ transplant.
5. Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
6. 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.
7. Subject has a history or presence of documented inflammatory bowel disease.

8. Subject is known to be positive for human immunodeficiency virus infection.

   -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: NGM Study Director; 650-243-5555; ngm120@ngmbio.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04068896
• Other Study ID Numbers: 18-0402
• Has Data Monitoring Committee: No

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

• Plan to Share IPD: No

• Responsible Party: NGM Biopharmaceuticals, Inc
• Study Sponsor: NGM Biopharmaceuticals, Inc
• Collaborators: Not Provided

Investigators

• Study Director: NGM Study Director; NGM Biopharmaceuticals, Inc

• PRS Account: NGM Biopharmaceuticals, Inc
• Verification Date: April 2021