A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Solid Tumor, Adult
In brief
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? 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.
Key facts
- Study ID
- NCT06265727
- Run by
- Corbus Pharmaceuticals Inc.
- People needed
- 348
- Starts
- 2024-04-01
- Expected to finish
- 2027-01-27
- Last updated by the study team
- 2026-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.
You may not qualify 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.
Where it is running
- University of Southampton — Southampton, United Kingdom (enrolling)
- City of Hope Cancer Center — Duarte, California, United States (enrolling)
- Moores Cancer Centre at UC San Diego Health — San Diego, California, United States (enrolling)
- Helen Diller Family Comprehensive Cancer Center - UCSF — San Francisco, California, United States (enrolling)
- Leeds University Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
- Guy's and St Thomas' Clinical Research Facility — London, United Kingdom (enrolling)
- Imperial Experimental Cancer Medicine Centre — London, United Kingdom (enrolling)
- The Christie Hospital — Manchester, United Kingdom (enrolling)
- University of Liverpool - Clatterbridge Medical Centre — Metropolitan Borough of Wirral, United Kingdom (enrolling)
- O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham — Birmingham, Alabama, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Florida Cancer Specialists — Orlando, Florida, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- Dana-Faber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Texas Oncology — Tyler, Texas, United States (enrolling)
- Fred Hutchinson Cancer Center at University of Washington — Seattle, Washington, United States (enrolling)
- ICM-Val d'Aurelle — Montpellier, France (enrolling)
- CHU de Poitiers — Poitiers, France (enrolling)
- Institut de Cancerologie de l'Ouest — Saint-Herblain, France (enrolling)
- Gustave Roussy — Villejuif, France (enrolling)
- Careggi University Hospital — Florence, Italy (enrolling)
- European Institute of Oncology IRCCS — Milan, Italy (enrolling)
- Fondazione Policlinico Gemelli, IRCCS — Rome, Italy (enrolling)
- Centro Richerche Cliniche di Verona — Verona, Italy (enrolling)
- Aresnsia Research Clinic Bucharest — Bucharest, Romania (enrolling)
Full record on ClinicalTrials.gov
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