Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Secondary Outcome Measures :
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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.