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

  • STATUS
    Recruiting
  • End date
    Jan 19, 2025
  • participants needed
    75
  • sponsor
    NGM Biopharmaceuticals, Inc
Updated on 7 October 2022
cancer
combination therapy
carcinoma
squamous cell carcinoma
lung cancer
pancreatic adenocarcinoma
esophageal cancer
gastric cancer
cancer chemotherapy
adenocarcinoma
solid tumour
ovarian cancer
bladder cancer
esophagus cancer
bladder tumor
immunomodulator
immunostimulant
immunostimulants
immunomodulators
pancreatic cancers
cancer, ovarian
cancer of the ovary
unresectable pancreatic cancer
metastatic pancreatic adenocarcinoma
lung carcinoma
immunologic adjuvant

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).

Details
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
Treatment Placebo, NGM120
Clinical Study IdentifierNCT04068896
SponsorNGM Biopharmaceuticals, Inc
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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

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
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