Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Kyowa Kirin, Inc.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

KRN330DRUG

Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (2)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: For up to12 weeks

Secondary Outcomes

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).

Time frame: For up to12 weeks

Data from ClinicalTrials.gov

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