New cocktail of drugs takes on Hard-to-Treat colon cancer
NCT ID NCT04660812
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested combinations of a new drug called etrumadenant (AB928) with other treatments in 227 people whose colorectal cancer had spread. The goal was to see if these combinations could shrink tumors or slow the cancer's growth. Participants received different drug mixes, including chemotherapy and immunotherapy, to find safer and more effective options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Etrumadenant (AB928) combined with other drugs (AB680, zimberelimab, bevacizumab, chemotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for people with metastatic colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (phase 1b/2) with a small number of participants, so results may not apply to all patients. The drug combinations may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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227 people
The number who actually took part.
- Started
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May 2021
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 than 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, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis * Exclusion Criteria for Cohorts A and B: * Prior treatment with immune checkpoint blockade therapies including anti-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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
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American Oncology Partners of Maryland PA
Bethesda, Maryland, 20817, United States
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Arizona Clinical Research Center Inc
Tucson, Arizona, 85715, United States
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Asan Medical Center | University of Ulsan College of Medicine
Seoul, 5538, South Korea
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Azienda Ospedaliera Niguarda Ca' Granda
Milan, 20141, Italy
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Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, 50134, Italy
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Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB, United Kingdom
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CHU la Miletrie
Poitiers, 86000, France
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Centre Georges Francois Leclerc
Dijon, 21000, France
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Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Clinica Universidad Navarra-Sede Madrid
Pamplona, 31008, Spain
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Complejo Hospitalario de Orense
Ourense, 32005, Spain
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Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, 89169, United States
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Corporacio Sanitaria Parc Tauli
Sabadell, 8208, Spain
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Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite
Paris, 75651, France
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Hopital Hotel Dieu
Nantes, 44093, France
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Hopital Saint Antoine
Paris, 75012, France
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Hospital General Universitario Gregorio Maranon
Madrid, 28046, Spain
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Hospital Universitario La Paz
Madrid, 28007, Spain
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IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, 70013, Italy
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Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076, France
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Instituto Europeo di Oncologia
Milan, 20162, Italy
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Istituto Clinico Humanitas IRCCS
Rozzano, 20089, Italy
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Korea University Anam Hospital
Seoul, 8241, South Korea
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Kyungpook National University Chilgok Hospital
Seoul, South Korea
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NYU Langone Medical Center - NYU Medical Oncology Associates
New York, New York, 10016, United States
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New York-Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032, United States
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Ochsner Medical Center (OMC)
New Orleans, Louisiana, 70121, United States
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Prisma Health-Upstate
Greenville, South Carolina, 29605, United States
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Samsung Medical Center
Seoul, 6351, South Korea
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Sarah Cannon Research Institute
Nashville, Tennessee, 37232, United States
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Seoul National University Bundang Hospital
Seoul, 13620, South Korea
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Seoul National University Hospital (SNUH)
Seoul, 3080, South Korea
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Severance Hospital | Yonsei University Health System
Seoul, 3722, South Korea
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016-2633, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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UCLA Hematology Oncology
Santa Monica, California, 90404, United States
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Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, 53100, Italy
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University of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322, United States
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Yale Cancer Center
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a daily pill replace chemotherapy for advanced colorectal cancer?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?