The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy or immune-priming radiotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy and immune-priming radiotherapy. For patients receiving the immune-priming radiotherapy they will receive three doses of radiotherapy focused on a single tumor. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.
Solid Tumor
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy or immune-priming radiotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy and immune-priming radiotherapy. For patients receiving the immune-priming radiotherapy they will receive three doses of radiotherapy focused on a single tumor. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.
First-in-human Study of CRB-601-01 to Treat Patients with Advanced Solid Tumor.
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University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294
SCRI - Arizona Oncology Associates, Tucson, Arizona, United States, 85711
The University of Arizona Cancer Center, Tucson, Arizona, United States, 85724
UC San Diego Health - Moores Cancer Center, La Jolla, California, United States, 92093
Cedars-Sinai Medical Center, Los Angeles, California, United States, 99048
University of California San Francisco, San Francisco, California, United States, 94143
SCRI - Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218
Advent Health Oncology Hematology, Orlando, Florida, United States, 32804
SCRI- Lake Nona DDU, Orlando, Florida, United States, 32827
University of Chicago, Chicago, Illinois, United States, 60637
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Corbus Pharmaceuticals Inc.,
Jeff Clarke, MD, PRINCIPAL_INVESTIGATOR, Duke University, NC, USA
Christian Ottensmeier, MD, PRINCIPAL_INVESTIGATOR, Liverpool University, UK
Dominic Smethurst, MD, STUDY_DIRECTOR, Corbus Pharmaceuticals Inc.
2026-12-01