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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRN330 | Drug | Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Berlin, M.D. | Ingram Professor of Cancer Research, Vanderbilt University | Principal Investigator |
| Howard A Burris, III, M.D. | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States | ||
| Vanderbilt-Ingram Cancer Center |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C581257 | KRN-330 |
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| Nashville |
| Tennessee |
| 37232 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |