A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas

Gilead Sciences2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2000年2月最近更新: 2021年8月19日

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试验速览

The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.

•Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
•Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA < 300 ng/mL
•Hepatic: Serum bilirubin </= 2.0 mg/dL, ALT < 2.5 x IULN
•Cardiovascular: Patients with LVEF >/= 40% by required MUGA/2D-ECHO study.
•Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests
•Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

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