RECRUITING

A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

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Conditions

Solid Tumor, Adultnectin-4

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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 goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.

Official Title

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-04-01
Study Completion:2027-01-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06265727

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 advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.
  1. * Active of uncontrolled CNS metastases
  2. * History of solid tumors other than the diseases under study
  3. * History of and/or current cardiovascular events or conditions in the previous 6 months
  4. * Pre-existing \>/= Grade 2 neuropathy
  5. * Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
  6. * Active ocular disease at baseline
  7. * Chronic severe liver disease or live cirrhosis
  8. * Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
  9. * Other significant cormorbidities.

Contacts and Locations

Study Contact

Ian Hodgson, PhD
CONTACT
+1 (617) 963-0105
Clinical@Corbuspharma.com
Rodney Carter, BSc
CONTACT
Clinical@Corbuspharma.com

Principal Investigator

David Pinato, MD
PRINCIPAL_INVESTIGATOR
Imperial College London
Ian Hodgson, PhD
STUDY_DIRECTOR
Corbus International Ltd
Ari Rosenberg, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

City of Hope Cancer Center
Duarte, California, 91010
United States
Moores Cancer Centre at UC San Diego Health
San Diego, California, 92037
United States
Helen Diller Family Comprehensive Cancer Center - UCSF
San Francisco, California, 94115
United States
Rocky Mountain Cancer Centres
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Florida Cancer Specialists
Orlando, Florida, 32806
United States
University of Chicago
Chicago, Illinois, 60637
United States
Hope and Healing Cancer Center
Hinsdale, Illinois, 60521
United States
Dana-Faber Cancer Institute
Boston, Massachusetts, 02215
United States
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506
United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
United States
Texas Oncology
Tyler, Texas, 75702
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Corbus Pharmaceuticals Inc.

  • David Pinato, MD, PRINCIPAL_INVESTIGATOR, Imperial College London
  • Ian Hodgson, PhD, STUDY_DIRECTOR, Corbus International Ltd
  • Ari Rosenberg, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

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 Date2024-04-01
Study Completion Date2027-01-27

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2027-01-27

Terms related to this study

Keywords Provided by Researchers

  • nectin-4

Additional Relevant MeSH Terms

  • Solid Tumor, Adult