New treatment for advanced solid tumors using CRB-601
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody Against Integrin avb8, in Patients With Advanced Solid Tumors
This study is testing a new treatment called CRB-601 for people with advanced solid tumors that haven't improved with other therapies to see how safe and effective it is.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corbus Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 26 sites (Birmingham, Alabama and 25 other locations) |
| Trial ID | NCT06603844 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of CRB-601, a monoclonal antibody targeting the avb8 integrin protein, in patients with advanced solid tumors who have not responded to other treatments. The trial consists of three parts, including dose escalation and combination therapies with immunotherapy and immune-priming radiotherapy. Researchers will assess side effects, blood levels of CRB-601, and its impact on cancer progression. The goal is to determine the optimal dosing and treatment combinations for patients with specific tumor types.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced solid tumors that have progressed after at least one line of therapy and express the avb8 integrin protein.
Not a fit: Patients with solid tumors that do not express the avb8 integrin protein or those with certain severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting specific tumor markers have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Birmingham, Alabama and 25 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
- SCRI - Arizona Oncology Associates — Tucson, Arizona, United States (Not_yet_recruiting)
- The University of Arizona Cancer Center — Tucson, Arizona, United States (Not_yet_recruiting)
- UC San Diego Health - Moores Cancer Center — La Jolla, California, United States (Not_yet_recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
- University of California San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- SCRI - Rocky Mountain Cancer Centers — Denver, Colorado, United States (Not_yet_recruiting)
- Advent Health Oncology Hematology — Orlando, Florida, United States (Not_yet_recruiting)
- SCRI- Lake Nona DDU — Orlando, Florida, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
- SCRI - Minnesota Oncology Hematology — Maple Grove, Minnesota, United States (Not_yet_recruiting)
- Nebraska Hematology Oncology — Lincoln, Nebraska, United States (Recruiting)
- Duke Cancer Center — Durham, North Carolina, United States (Not_yet_recruiting)
- University Hospital of Cleveland (Case Western) — Cleveland, Ohio, United States (Not_yet_recruiting)
- SCRI - OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
- SCRI - Nashville — Nashville, Tennessee, United States (Recruiting)
- START - San Antonio — San Antonio, Texas, United States (Recruiting)
- SCRI- Texas Oncology — Tyler, Texas, United States (Not_yet_recruiting)
- SCRI - Virginia Cancer Specialists — Fairfax, Virginia, United States (Not_yet_recruiting)
- SCRI - Oncology and Hematology Associates of Southwest Virginia — Roanoke, Virginia, United States (Not_yet_recruiting)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne and Wear, United Kingdom (Not_yet_recruiting)
- The Christie NHS Foundation Trust - Christie Hospital — Manchester, United Kingdom, United Kingdom (Not_yet_recruiting)
- The Clatterbridge Cancer Center NHS Foundation Trust — Birkenhead, Wirral, United Kingdom (Not_yet_recruiting)
- Edinburgh Cancer Research Centre — Edinburgh, United Kingdom (Not_yet_recruiting)
- Beatson West of Scotland Cancer Center — Glasgow, United Kingdom (Not_yet_recruiting)
- Guys and St Thomas NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Jeff Clarke, MD — Duke University, NC, USA
- Study coordinator: Ian Hodgson, PhD
- Email: Ian.Hodgson@corbuspharma.com
- Phone: 617-963-0100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.