A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
NCT ID: NCT06265727
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
348 participants
INTERVENTIONAL
2024-04-01
2027-01-27
Brief Summary
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The main questions it aims to answer are:
What is the the safe and effective dose of CRB-701? 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. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.
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Detailed Description
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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 Maximum Tolerated Dose (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 evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 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 recommended dose level of CRB-701 for further exploration defined in Part B will explore CRB-701 alone or combined with anti-PD-1 in up to seven separate cohorts of participants with advanced tumors known to express Nectin-4.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A Dose Escalation - CRB-701 Dose Level 1
CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part A Dose Escalation - CRB-701 Dose Level 2
CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part A Dose Escalation - CRB-701 Dose Level 3
CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part A Dose Escalation - CRB-701 Dose Level 4
CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part B Dose Optimization: CRB-701 High dose
Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part B Dose Optimization: CRB-701 low dose
Selected Low dose of CRB-701, intravenous infusion over 30 mins
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part C Dose Expansion - Cohort 1
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Part C Dose Expansion - Cohort 2
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part C Dose Expansion - Cohort 3
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Part C Dose Expansion - Cohort 4
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part C Dose Expansion - Cohort 5
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1
Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1
Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Part C Dose Expansion - Cohort 6
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Part C Dose Expansion - Cohort 7
Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Interventions
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CRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
Anti-PD-1
checkpoint inhibitor
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of solid tumors other than the diseases under study
* History of and/or current cardiovascular events or conditions in the previous 6 months
* Pre-existing \>/= Grade 2 neuropathy
* Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
* Active ocular disease at baseline
* Chronic severe liver disease or live cirrhosis
* Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
* Other significant cormorbidities.
18 Years
ALL
No
Sponsors
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CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
INDUSTRY
Corbus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Pinato, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Ian Hodgson, PhD
Role: STUDY_DIRECTOR
Corbus International Ltd
Ari Rosenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham
Birmingham, Alabama, United States
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
Fred Hutchinson Cancer Center at University of Washington
Seattle, Washington, United States
ICM-Val d'Aurelle
Montpellier, , France
CHU de Poitiers
Poitiers, , France
Institut de Cancerologie de l'Ouest
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Careggi University Hospital
Florence, , Italy
European Institute of Oncology IRCCS
Milan, , Italy
Fondazione Policlinico Gemelli, IRCCS
Rome, , Italy
Centro Richerche Cliniche di Verona
Verona, , Italy
Institute of Oncology/ARENSIA Exploratory Medicine
Chisinau, , Moldova
Aresnsia Research Clinic Bucharest
Bucharest, , Romania
Aresnsia Research Clinic Cluj-Napoca
Cluj-Napoca, , Romania
Centrul de Oncologie Sf. Nectarie
Iași, , Romania
Centrul de Oncologie Euroclinic
Iași, , Romania
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
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 Liverpool - Clatterbridge Medical Centre
Metropolitan Borough of Wirral, , United Kingdom
University of Southampton
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Rodney Carter
Role: primary
Other Identifiers
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CRB-701-01
Identifier Type: -
Identifier Source: org_study_id
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