RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-04
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06603844

Participation Criteria

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
  3. * Life expectancy of more than 12 weeks.
  4. * Adequate hematologic and end-organ function.
  1. * History of solid tumor malignancies other than the disease under study within 3 years of study enrollment
  2. * History of and/or current cardiovascular events or conditions
  3. * Chronic severe liver disease or liver cirrhosis
  4. * Systemic autoimmune disease
  5. * Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes.
  6. * Interstitial lung disease within 6 months of study enrollment.
  7. * Active or persistent infection
  8. * Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.

Contacts and Locations

Study Contact

Ian Hodgson, PhD
CONTACT
617-963-0100
Ian.Hodgson@corbuspharma.com

Principal Investigator

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.

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
SCRI - Arizona Oncology Associates
Tucson, Arizona, 85711
United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
UC San Diego Health - Moores Cancer Center
La Jolla, California, 92093
United States
Cedars-Sinai Medical Center
Los Angeles, California, 99048
United States
University of California San Francisco
San Francisco, California, 94143
United States
SCRI - Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
Advent Health Oncology Hematology
Orlando, Florida, 32804
United States
SCRI- Lake Nona DDU
Orlando, Florida, 32827
United States
University of Chicago
Chicago, Illinois, 60637
United States
SCRI - Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369
United States
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
University Hospital of Cleveland (Case Western)
Cleveland, Ohio, 44106
United States
SCRI - OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
SCRI - Nashville
Nashville, Tennessee, 37203
United States
START - San Antonio
San Antonio, Texas, 78229
United States
SCRI- Texas Oncology
Tyler, Texas, 75702
United States
SCRI - Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
SCRI - Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: 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.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor