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Brief Title: A Phase 1/2 Study to Investigate CRB-701 in Solid 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
Study ID: NCT06265727
Brief Summary: 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.
Detailed Description: This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4. Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the MTD of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT. Part B will determine the RP2D of CRB-701 by evaluating two dose levels of CRB-701 by using a time-to-event Bayesian optimal Phase 2 (TOP) study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors. During Part C, the RP2D dose of CRB-701 will be evaluated in five planned expansion cohorts using Simon's optimal two-stage design.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Cancer Center, Duarte, California, United States
Moores Cancer Centre at UC San Diego Health, San Diego, California, United States
Helen Diller Family Comprehensive Cancer Center - UCSF, San Francisco, California, United States
Rocky Mountain Cancer Centres, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Florida Cancer Specialists, Orlando, Florida, United States
University of Chicago, Chicago, Illinois, United States
Hope and Healing Cancer Center, Hinsdale, Illinois, United States
Dana-Faber Cancer Institute, Boston, Massachusetts, United States
Nebraska Hematology Oncology, Lincoln, Nebraska, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Texas Oncology, Tyler, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Barcelona IOB Hospital Quironsalud (NEXT), Barcelona, , Spain
Vall d-Hebron Institut d'Oncologia, Barcelona, , Spain
Fundacion Jimenez Diaz (START), Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital), Adana, , Turkey
Ankara Etlik City Hospital, Ankara, , Turkey
Ankara University, Ankara, , Turkey
Istanbul Medeniyet University, Istanbul, , Turkey
University of Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
University of Cambridge NHS Foundation Trust, Cambridge, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Leeds University Hospitals NHS Trust, Leeds, , United Kingdom
Guy's and St Thomas' Clinical Research Facility, London, , United Kingdom
Imperial Experimental Cancer Medicine Centre, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
University of Southampton, Southampton, , United Kingdom
University of Liverpool - Clatterbridge Medical Centre, Wirral, , United Kingdom
Name: David Pinato, MD
Affiliation: Imperial College London
Role: PRINCIPAL_INVESTIGATOR
Name: Ian Hodgson, PhD
Affiliation: Corbus International Ltd
Role: STUDY_DIRECTOR
Name: Ari Rosenberg, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR