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

Last updated: December 23, 2024
Sponsor: Corbus Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

CRB-701

Clinical Study ID

NCT06265727
CRB-701-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solidtumors that have progressed following at least one line of therapy or have no otherstandard therapy with proven clinical benefit.

Exclusion

Exclusion Criteria:

  • Active of uncontrolled CNS metastases

  • History of solid tumors other than the diseases under study

  • History of and/or current cardiovascular events or conditions in the previous 6months

  • Pre-existing >/= Grade 2 neuropathy

  • Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabeticneuropathy

  • Active ocular disease at baseline

  • Chronic severe liver disease or live cirrhosis

  • Interstitial lung disease or pneumonitis within 6 months on initiating treatment onstudy

  • Other significant cormorbidities.

Study Design

Total Participants: 420
Treatment Group(s): 1
Primary Treatment: CRB-701
Phase: 1/2
Study Start date:
April 01, 2024
Estimated Completion Date:
January 27, 2027

Study 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.

Connect with a study center

  • ICM-Val d'Aurelle

    Montpellier, 34298
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86000
    France

    Site Not Available

  • Institut de Cancerologie de l'Ouest

    St. Herblain, 44085
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Careggi University Hospital

    Florence, 50314
    Italy

    Site Not Available

  • European Institute of Oncology IRCCS

    Milan, 20141
    Italy

    Site Not Available

  • Fondazione Policlinico Gemelli, IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • Centro Richerche Cliniche di Verona

    Verona, 37134
    Italy

    Site Not Available

  • Aresnsia Research Clinic Bucharest

    Bucharest, 22328
    Romania

    Site Not Available

  • Aresnsia Research Clinic Cluj-Napoca

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Centrul de Oncologie Euroclinic

    Lasi, 700106
    Romania

    Site Not Available

  • Centrul de Oncologie Sf. Nectarie

    Lasi, 200347
    Romania

    Site Not Available

  • Barcelona IOB Hospital Quironsalud (NEXT)

    Barcelona, 08023
    Spain

    Site Not Available

  • Vall d-Hebron Institut d'Oncologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz (START)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital)

    Adana, 83114
    Turkey

    Site Not Available

  • Ankara Etlik City Hospital

    Ankara,
    Turkey

    Site Not Available

  • Ankara University

    Ankara, 06620
    Turkey

    Site Not Available

  • Istanbul Medeniyet University

    Istanbul, 34720
    Turkey

    Site Not Available

  • University of Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • University of Cambridge NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Velindre Cancer Centre

    Cardiff, CF15 7QZ
    United Kingdom

    Site Not Available

  • Leeds University Hospitals NHS Trust

    Leeds, LS9 7LP
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' Clinical Research Facility

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Imperial Experimental Cancer Medicine Centre

    London, W12 0NN
    United Kingdom

    Active - Recruiting

  • The Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • University of Southampton

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University of Liverpool - Clatterbridge Medical Centre

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • City of Hope Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Moores Cancer Centre at UC San Diego Health

    San Diego, California 92037
    United States

    Active - Recruiting

  • Helen Diller Family Comprehensive Cancer Center - UCSF

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centres

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Hope and Healing Cancer Center

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Dana-Faber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Nebraska Hematology Oncology

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Texas Oncology

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center at University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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