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

Description

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.

Conditions

Solid Tumor, Adult

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Cancer Center, Duarte, California, United States, 91010

San Diego

Moores Cancer Centre at UC San Diego Health, San Diego, California, United States, 92037

San Francisco

Helen Diller Family Comprehensive Cancer Center - UCSF, San Francisco, California, United States, 94115

Denver

Rocky Mountain Cancer Centres, Denver, Colorado, United States, 80218

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06510

Orlando

Florida Cancer Specialists, Orlando, Florida, United States, 32806

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Hinsdale

Hope and Healing Cancer Center, Hinsdale, Illinois, United States, 60521

Boston

Dana-Faber Cancer Institute, Boston, Massachusetts, United States, 02215

Lincoln

Nebraska Hematology Oncology, Lincoln, Nebraska, United States, 68506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Corbus Pharmaceuticals Inc.,

David Pinato, MD, PRINCIPAL_INVESTIGATOR, Imperial College London

Ian Hodgson, PhD, STUDY_DIRECTOR, Corbus International Ltd

Ari Rosenberg, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2027-01-27