An Open Label Study Evaluating the Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer.

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    250
  • sponsor
    Arcus Biosciences, Inc.
Updated on 6 September 2021

Summary

This randomized phase 1b/2 open-label study will evaluate the efficacy of etrumadenant (AB928) treatment combinations in patients with metastatic colorectal cancer.

Description

This is a multicenter, open-label Phase 1b/2 study in participants with metastatic colorectal cancer that will assess the efficacy of etrumadenant.

Approximately 250 participants will be enrolled to 1 of 3 cohorts:

Cohort A) etrumadenant + zimberelimab +mFOLFOX-6 +/-bev vs mFOLFOX-6 +/-Bev

Cohort B) etrumadenant + zimberelimab +mFOLFOX-6 +/-bev 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.

Details
Condition Metastatic Colorectal Cancer
Treatment Regorafenib, bevacizumab, AB680, Zimberelimab, Etrumadenant, mFOLFOX-6 regimen, mFOLFOX-6 regimen
Clinical Study IdentifierNCT04660812
SponsorArcus Biosciences, Inc.
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previous anticancer treatment within 4 weeks prior to initiation of study treatment
Prior allogeneic stem cell or solid organ transplant
Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
Use of any live vaccines against infectious diseases within 28 days of first dose
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Current treatment with anti-viral therapy for HBV
Structurally unstable bone lesions suggesting impending fracture
History or leptomeningeal disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ
Active tuberculosis
Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment
Severe infection within 4 weeks (28 days) prior to initiation of study treatment
Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia
Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study
Known allergy or hypersensitivity to any of the study drugs or their excipients
Inability to swallow medications
Malabsorption condition that would alter the absorption of orally administered medications
Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
Prior treatment with an agent targeting the adenosine pathway
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjgren syndrome, Guillain Barr syndrome, or multiple sclerosis
Exclusion Criteria for Cohorts A and B
Prior treatment with immune checkpoint blockade therapies including anit-cytotoxic T lymphocyte-associated protein-4, anti PD-1, and anti-PD-L1 therapeutic antibodies
Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening
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