An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.
Colon/Rectal Cancer
Unknown Primary
18 Years and older, Male and Female
ARC-9 (primary)
NCI-2021-02881
2020-005386-13
Summary
This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety
of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal
cancer.
Objectives
This is a multicenter, open-label Phase 1b/2 study in participants with metastatic colorectal
cancer that will assess the antitumour activity and safety of etrumadenant.
Approximately 250 participants will be enrolled to 1 of 3 cohorts:
Cohort A) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs mFOLFOX-6 +/-bevacizumab
Cohort B) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs regorafenib
Cohort C) chemotherapy-free combinations of etrumadenant + zimberelimab + other agents
The primary objective of this clinical study is to evaluate the safety of etrumadenant-based
combination therapy in participants with metastatic colorectal cancer.
Eligibility
- Male and female participants = 18 years of age
- Histologically confirmed metastatic colorectal adenocarcinoma
- Must have at least 1 measurable lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 3 months
- Adequate hematologic and end-organ function
- Negative HIV, Hep B and Hep C antibody testing
- Agreement to remain abstinent or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, 180 days after mFOLFOX-6 and 180 days after bev, whichever is longer.
- Inclusion Criteria for Cohort A:
- Disease progression following not more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent
- Inclusion Criteria for Cohort B:
- Disease progression during or following not more that two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent
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