Corbus Pharmaceuticals Inc.
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.
Solid Tumor, Adult
CRB-701
PHASE1
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 420 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| 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 |
| Actual Study Start Date : | 2024-04-01 |
| Estimated Primary Completion Date : | 2027-01-16 |
| Estimated Study Completion Date : | 2027-01-27 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham
Birmingham, Albama, United States, 35294
RECRUITING
City of Hope Cancer Center
Duarte, California, United States, 91010
RECRUITING
Moores Cancer Centre at UC San Diego Health
San Diego, California, United States, 92037
RECRUITING
Helen Diller Family Comprehensive Cancer Center - UCSF
San Francisco, California, United States, 94115
RECRUITING
Rocky Mountain Cancer Centres
Denver, Colorado, United States, 80218
RECRUITING
Yale Cancer Center
New Haven, Connecticut, United States, 06510
RECRUITING
Florida Cancer Specialists
Orlando, Florida, United States, 32806
RECRUITING
University of Chicago
Chicago, Illinois, United States, 60637
RECRUITING
Hope and Healing Cancer Center
Hinsdale, Illinois, United States, 60521
RECRUITING
Dana-Faber Cancer Institute
Boston, Massachusetts, United States, 02215
RECRUITING
Nebraska Hematology Oncology
Lincoln, Nebraska, United States, 68506
RECRUITING
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
RECRUITING
Texas Oncology
Tyler, Texas, United States, 75702
RECRUITING
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
RECRUITING
Fred Hutchinson Cancer Center at University of Washington
Seattle, Washington, United States, 98195
NOT YET RECRUITING
ICM-Val d'Aurelle
Montpellier, France, 34298
NOT YET RECRUITING
Poitiers of chu
Poitiers, France, 86000
NOT YET RECRUITING
West Cancerology Institute
St. Herblain, France, 44085
NOT YET RECRUITING
Gustave Roussy
Villejuif, France, 94805
NOT YET RECRUITING
Careggi University Hospital
Florence, Italy, 50314
NOT YET RECRUITING
European Institute of Oncology IRCCS
Milan, Italy, 20141
NOT YET RECRUITING
Gemelli Polyclinic Foundation, IRCCS
Rome, Italy, 00168
NOT YET RECRUITING
Clinical Research Center of Verona
Verona, Italy, 37134
NOT YET RECRUITING
Aresnsia Research Clinic Bucharest
Bucharest, Romania, 22328
NOT YET RECRUITING
ARENSIA Research Clinic Cluj-Napoca
Cluj-Napoca, Romania, 400015
NOT YET RECRUITING
The Center of Oncology St. Nectarie
Shot, Romania, 200347
NOT YET RECRUITING
Eurocinic oncology Center
Shot, Romania, 700106
NOT YET RECRUITING
Barcelona IOb Quironsalud Hospital (Next)
Barcelona, Spain, 08023
NOT YET RECRUITING
D-Hebron Valley Institute of Oncology
Barcelona, Spain, 08035
NOT YET RECRUITING
Fundacion Jimenez Diaz (Start)
Madrid, Spain, 28040
NOT YET RECRUITING
University Clinic Hospital of Valencia
Valencia, Spain, 46010
NOT YET RECRUITING
Adana Numune Education and Research Hospital (Adana City Education and Research Hospital)
Adana, Turkey, 83114
NOT YET RECRUITING
Ankara University
Ankara, Turkey, 06620
NOT YET RECRUITING
Ankara Etlik City Hospital
Ankara, Turkey,
NOT YET RECRUITING
Istanbul Medeniyet University
Istanbul, Turkey, 34720
NOT YET RECRUITING
University of Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2th
RECRUITING
University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
NOT YET RECRUITING
Velindre Cancer Center
Cardiff, United Kingdom, CF15 7QZ
RECRUITING
Leeds University Hospitals NHS Trust
Leeds, United Kingdom, Paste
RECRUITING
Guy's and St Thomas' Clinical Research Facility
London, United Kingdom, SE1 9RT
RECRUITING
Imperial Experimental Cancer Medicine Centre
London, United Kingdom, W12 0NN
RECRUITING
The Christie Hospital
Manchester, United Kingdom, M20 4BX
NOT YET RECRUITING
University of Southampton
Southampton, United Kingdom, SO16 6YD
NOT YET RECRUITING
University of Liverpool - Clatterbridge Medical Centre
Wirral, United Kingdom, CH63 4JY