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

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

INTRODUCTION

  • Org Study ID: 18-0402
  • Secondary ID: N/A
  • NTC ID: NCT04068896
  • Sponsor: NGM Biopharmaceuticals, Inc

BRIEF SUMMARY

Study of NGM120 in subjects with advanced solid tumors and and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).

  • Overall Status
    Recruiting
  • Start Date
    October 16, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of patients with Dose-Limiting Toxicities:

Primary Outcome 1 - Timeframe: 12 weeks

Primary Outcome 2 - Measure: Incidence of Adverse Events

Primary Outcome 2 - Timeframe: 12 weeks

Primary Outcome 3 - Measure: Number of Patients with Clinically Significant Laboratory Abnormalities:

Primary Outcome 3 - Timeframe: 12 weeks

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
  • Prostate Cancer

ELIGIBILITY

Inclusion Criteria (Part 1 and 2):
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.

- Life expectancy of at least 12 weeks

- Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period.

- Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible.
Inclusion Criteria (Part 3 Prostate Cancer):
Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.

- Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L). - Have serum GDF15 levels ≥1300 pg/mL. - Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy. - Have had PSA doubling time of >3 months.
Exclusion Criteria (All parts):
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 (HIV) infection.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: NGM Study Director

Role: Study Director

Affiliation: NGM Biopharmaceuticals, Inc

Overall Contact

Name: NGM Study Director

Phone: 650-243-5555

Email: ngm120@ngmbio.com

LOCATION

Facility Status Contact
Facility: NGM Clinical Study Site
Tucson, Arizona 85719
United States
Status: Recruiting Contact: Contact
NGM Site 129

Facility: NGM Clinical Study Site
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
NGM Site 122

Facility: NGM Clinical Study Site
Los Angeles, California 90084
United States
Status: Recruiting Contact: Contact
NGM Site 105

Facility: NGM Clinical Study Site
San Diego, California 92123
United States
Status: Recruiting Contact: Contact
NGM Site 102

Facility: NGM Clinical Study Site
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
NGM Site 110

Facility: NGM Clinical Study Site
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
NGM Site 117

Facility: NGM Clinical Study Site
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
NGM Site 119

Facility: NGM Clinical Study Site
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Site 132

Facility: NGM Clinical Study Site
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: Contact
NGM Site 124

Facility: NGM Clinical Study Site
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
NGM Site 118

Facility: NGM Clinical Study Site
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Seattle, Washington 98101
United States
Status: Recruiting Contact: N/A