First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy 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. 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.

Key facts

Study ID

NCT06603844

Run by

Corbus Pharmaceuticals Inc.

People needed

156

Starts

2024-12-04

Expected to finish

2026-12-01

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available.
• Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
• Life expectancy of more than 12 weeks.
• Adequate hematologic and end-organ function.

You may not qualify if…

• History of solid tumor malignancies other than the disease under study within 3 years of study enrollment
• History of and/or current cardiovascular events or conditions
• Chronic severe liver disease or liver cirrhosis
• Systemic autoimmune disease
• Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.
• Interstitial lung disease within 6 months of study enrollment.
• Active or persistent infection
• Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.

Where it is running

• SCRI- Lake Nona DDU — Orlando, Florida, United States (enrolling)
• SCRI - Nashville — Nashville, Tennessee, United States (enrolling)
• START - San Antonio — San Antonio, Texas, United States (enrolling)
• Nebraska Hematology Oncology — Lincoln, Nebraska, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• SCRI - Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Advent Health Oncology Hematology — Orlando, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• SCRI - Minnesota Oncology Hematology — Maple Grove, Minnesota, United States
• Duke Cancer Center — Durham, North Carolina, United States
• University Hospital of Cleveland (Case Western) — Cleveland, Ohio, United States
• SCRI - OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• SCRI- Texas Oncology — Tyler, Texas, United States
• SCRI - Virginia Cancer Specialists — Fairfax, Virginia, United States
• SCRI - Oncology and Hematology Associates of Southwest Virginia — Roanoke, Virginia, United States
• The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne and Wear, United Kingdom
• The Christie NHS Foundation Trust - Christie Hospital — Manchester, United Kingdom, United Kingdom
• The Clatterbridge Cancer Center NHS Foundation Trust — Birkenhead, Wirral, United Kingdom
• Edinburgh Cancer Research Centre — Edinburgh, United Kingdom
• Beatson West of Scotland Cancer Center — Glasgow, United Kingdom
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Guys and St Thomas NHS Foundation Trust — London, United Kingdom
• SCRI - Arizona Oncology Associates — Tucson, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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