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

N

NGM Biopharmaceuticals

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

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

Treatments

Biological: NGM120
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04068896
18-0402

Details and patient eligibility

About

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).

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

75 participants in 7 patient groups, including a placebo group

NGM120 Dose 1
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
NGM120 Dose 2
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
NGM120 Dose 3
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
NGM120 Dose 4
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
NGM120 Dose 5
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
NGM120 Dose 6
Experimental group
Description:
NGM120 Subcutaneous Injection
Treatment:
Biological: NGM120
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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