RECRUITING
I'm interested ...!!
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
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
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 16 January 2027
✅ Study Completion (Estimated) 27 January 2027
👥 Enrollment (Estimated) 420
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Duarte, California, United States
📍 San Diego, California, United States
📍 San Francisco, California, United States
📍 Denver, Colorado, United States
📍 New Haven, Connecticut, United States
📍 Orlando, Florida, United States
📍 Chicago, Illinois, United States
📍 Hinsdale, Illinois, United States
📍 Boston, Massachusetts, United States
📍 Lincoln, Nebraska, United States
📍 Huntersville, North Carolina, United States
📍 Tyler, Texas, United States
📍 Fairfax, Virginia, United States
📍 Barcelona, Spain
📍 Barcelona, Spain
📍 Madrid, Spain
📍 Valencia, Spain
📍 Adana, Turkey
📍 Ankara, Turkey
📍 Ankara, Turkey
📍 Istanbul, Turkey
📍 Birmingham, United Kingdom
📍 Cambridge, United Kingdom
📍 Cardiff, United Kingdom
📍 Leeds, United Kingdom
📍 London, United Kingdom
📍 London, United Kingdom
📍 Manchester, United Kingdom
📍 Southampton, United Kingdom
📍 Wirral, United Kingdom
More locations available...

📋 Eligibility Criteria

Description

    Inclusion 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.

    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 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 N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 February 2024
  • First Submitted that Met QC Criteria 12 February 2024
  • First Posted 20 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 May 2024
  • Last Update Posted 13 May 2024
  • Last Verified May 2024
I'm interested ...!!