๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-29

First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor. (NCT06603844)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Corbus Pharmaceuticals Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

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

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 963-0100

Email: Ian.Hodgson@corbuspharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Solid Tumor clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—