Colorectal Cancer
Conditions
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.
Interventions
DRUGKRN330
Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
Sponsors
Kyowa Kirin, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease. 2. Are not candidates for a surgically curative procedure. 3. Have progressed despite, are intolerant of, or are not appropriate for current therapies.
Exclusion criteria
1. Have an active, uncontrolled infection. 2. Have known or suspected cerebral metastasis. 3. 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). 4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results. 5. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed