Clinical trial NCT04068896: Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.

Eligibility criteria: Inclusion Criteria (Part 1 and 2):

1. 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.
3. Life expectancy of at least 12 weeks
4. 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.
5. 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):

1. Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
2. Effective castration with serum testosterone levels \<0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
3. Have serum GDF15 levels ≥1300 pg/mL.
4. 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.
5. Have had PSA doubling time of \>3 months.

Exclusion Criteria (All parts):

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 (HIV) infection.

Primary outcomes:
measure: To Determine the Safety and Tolerability of NGM120 in Subjects
timeFrame: From enrollment to end of treatment up to 24 months
measure: To Determine the Safety and Tolerability of NGM120
timeFrame: From enrollment to end of treatment up to 24 months
measure: To Determine the Safety and Tolerability of NGM120
timeFrame: From enrollment to end of treatment up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: NGM Clinical Study Site
state: Arizona
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Sacramento
country: United States
facility: NGM Clinical Study Site
state: California
city: San Diego
country: United States
facility: NGM Clinical Study Site
state: California
city: Santa Monica
country: United States
facility: NGM Clinical Study Site
state: California
city: Aurora
country: United States
facility: NGM Clinical Study Site
state: Colorado
city: Washington
country: United States
facility: NGM Clinical Study Site
state: District of Columbia
city: Miami
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Chicago
country: United States
facility: NGM Clinical Study Site
state: Illinois
city: Baltimore
country: United States
facility: NGM Clinical Study Site
state: Maryland
city: Cincinnati
country: United States
facility: NGM Clinical Study Site
state: Ohio
city: Philadelphia
country: United States
facility: NGM Clinical Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: NGM Clinical Study Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: NGM Clinical Study Site
state: South Carolina
city: Nashville
country: United States
facility: NGM Clinical Study Site
state: Tennessee
city: Dallas
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Seattle
country: United States
facility: NGM Clinical Study Site
state: Washington
city: Milwaukee
country: United States
facility: NGM Clinical Study Site
state: Wisconsin
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: NGM Study Director
role: STUDY_DIRECTOR
References: