Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
1 other identifier
interventional
42
1 country
2
Brief Summary
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Jun 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedApril 29, 2024
April 1, 2024
2.6 years
December 14, 2007
April 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
For up to12 weeks
Secondary Outcomes (1)
The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD).
For up to12 weeks
Interventions
Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
Eligibility Criteria
You may qualify if:
- Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
- Are not candidates for a surgically curative procedure.
- Have progressed despite, are intolerant of, or are not appropriate for current therapies.
You may not qualify if:
- Have an active, uncontrolled infection.
- Have known or suspected cerebral metastasis.
- Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
- Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
- Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan Berlin, M.D.
Ingram Professor of Cancer Research, Vanderbilt University
- PRINCIPAL INVESTIGATOR
Howard A Burris, III, M.D.
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
June 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 29, 2024
Record last verified: 2024-04