A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies

Completed · Phase 1

Conditions studied: GastroEsophageal Cancer, Colorectal Cancer

In brief

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).

Key facts

Study ID

NCT03720678

Run by

Arcus Biosciences, Inc.

People needed

44

Starts

2018-11-18

Expected to finish

2021-06-25

Last updated by the study team

2024-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants ≥ 18 years
• Histologically confirmed gastroesophageal cancer or colorectal cancer that is metastatic, advanced or recurrent with progression
• Participants for whom mFOLFOX is considered appropriate therapy
• Must have at least 1 measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Must have received standard of care, including potentially curative available therapies or interventions.
• Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion must be obtained.
• Adequate organ and marrow function
• Previously treated central nervous system metastases, meeting the following criteria:
• No evidence of progression by magnetic resonance imaging for at least 4 weeks prior to first dose.
• Neurologic symptoms returned to baseline.
• No immunosuppressive doses of systemic corticosteroids for at least 2 weeks before investigational product administration.
• No carcinomatous meningitis.

You may not qualify if…

• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
• Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous (eg interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant in combination with mFOLFOX.
• Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
• Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study.
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, breast, or prostate.
• Prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 4 weeks prior to Day 1 or has not recovered (ie, ≥ Grade 1 or baseline) from AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy and other AEs ≤ Grade 2 considered not clinically significant by the Medical Monitor and Investigator.
• Use of other investigational drugs (drugs not marketed for any indication) within 28 days of investigational product administration.

Where it is running

• Arizona Clinical Research Center — Tucson, Arizona, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Maryland Oncology Hematology — Rockville, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Texas Oncology - Austin Midtown — Austin, Texas, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology - Fort Worth Cancer Center — Fort Worth, Texas, United States
• Texas Oncology - San Antonio Northeast — San Antonio, Texas, United States
• Texas Oncology - San Antonio Medical Center — San Antonio, Texas, United States
• Texas Oncology - Tyler — Tyler, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Border Medical Oncology — Albury, New South Wales, Australia
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• The Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
• St. George Private Hospital — Kogarah, New South Wales, Australia
• Macquarie University Hospital — Macquarie Park, New South Wales, Australia
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia
• Cabrini Hospital — Malvern, Victoria, Australia

Full record on ClinicalTrials.gov

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