for people ages 18 years and up (full criteria)
study started
completion around



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


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.


Solid Tumor, Adult, nectin-4, Neoplasms, CRB-701


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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 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.


  • Moores Cancer Centre at UC San Diego Health not yet accepting patients
    San Diego California 92037 United States
  • Helen Diller Family Comprehensive Cancer Center - UCSF not yet accepting patients
    San Francisco California 94115 United States
  • Nebraska Hematology Oncology accepting new patients
    Lincoln Nebraska 68506 United States
  • Hope and Healing Cancer Center accepting new patients
    Hinsdale Illinois 60521 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Corbus Pharmaceuticals Inc.
Phase 1/2 research study
Study Type
Expecting 420 study participants
Last Updated