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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Etrumadenant is an A2aR and A2bR antagonist.
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
Arizona Clinical Research Center
Tucson, Arizona, United States
Incidence of Adverse Events (AEs)
Time frame: From first dose date to 90 days after the last dose (Approximately 1 year)
Incidence of dose-limiting toxicities (DLTs) during dose escalation phase
Time frame: From first dose date to 28 days after the first dose
Plasma concentration of etrumadenant
Time frame: 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)
Percentage of participants with Objective Response as determined by Investigator according to RECIST v1.1
Time frame: From study enrolment until participation discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)
Percentage of participants with Disease Control (complete response, partial response, or stable disease) for > 6 months as determined by RECIST v1.1
Time frame: From study enrolment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Duration of Response as determined by the Investigator according to RECIST v1.1
Time frame: 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)
Progression Free Survival (PFS) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 14 more locations
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
Time frame: From start of treatment up to death from any cause (up to approximately 3-5 years)
Receptor Occupancy in peripheral blood
Time frame: 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.
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
Time frame: 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.