New treatment for advanced solid tumors using CRB-601

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• SCRI- Lake Nona DDU
  Orlando, Florida, United States Recruiting
• Nebraska Hematology Oncology
  Lincoln, Nebraska, United States Recruiting
• SCRI - Nashville
  Nashville, Tennessee, United States Recruiting
• START - San Antonio
  San Antonio, Texas, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Not yet recruiting
• SCRI - Arizona Oncology Associates
  Tucson, Arizona, United States 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.