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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03720678
Other study ID # ARC-3 (AB928CSP0003)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 18, 2018
Est. completion date June 25, 2021

Study information

Verified date May 2024
Source Arcus Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

In the dose escalation phase, escalating doses of etrumadenant in combination with mFOLFOX at standard doses will be assessed in participants with advanced metastatic GEC or CRC. Eligible participants will receive oral administration of etrumadenant as well as IV infusion of mFOLFOX. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase. In the dose expansion phase, etrumadenant at the RDE in combination with mFOLFOX at standard doses may be assessed in participants with advanced metastatic GEC or CRC. Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 25, 2021
Est. primary completion date January 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Drug:
etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
mFOLFOX
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Arcus Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs) From first dose date to 90 days after the last dose (Approximately 1 year)
Primary Incidence of dose-limiting toxicities (DLTs) during dose escalation phase From first dose date to 28 days after the first dose
Secondary Plasma concentration of etrumadenant Recorded at baseline (prior to first dose), during the first 4 cycles of treatment (2 months), at end of treatment and 30 days post end of treatment (i.e. in total approximately 3 months)
Secondary Percentage of participants with Objective Response as determined by Investigator according to RECIST v1.1 From study enrolment until participation discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)
Secondary Percentage of participants with Disease Control (complete response, partial response, or stable disease) for > 6 months as determined by RECIST v1.1 From study enrolment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Secondary Duration of Response as determined by the Investigator according to RECIST v1.1 From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary Progression Free Survival (PFS) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 From start of treatment up to first occurrence of progressive disease or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary Overall Survival (OS) as determined by the Investigator according to RECIST v1.1 From start of treatment up to death from any cause (up to approximately 3-5 years)
Secondary Receptor Occupancy in peripheral blood Cycle 1 Day 1 through Cycle 4 Day 1 (2 months), at end of treatment and 30 days after end of treatment (in total approximately 3 months). Each Cycle is 14 days.
Secondary Immunomodulatory activity in subsets for AB928 in combination with mFOLFOX Immunomodulatory activity will be assessed by aggregating data from biomarkers collected from peripheral blood samples Cycle 1 Day 1 through Cycle 4 Day 1 (2 months), at end of treatment and 30 days after end of treatment (in total approximately 3 months). Each Cycle is 14 days.
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