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This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).
Twenty-seven (27) evaluable patients for overall response rate (ORR) will be enrolled in Stage 1. If four or more responses are observed in Stage 1, an additional 15 evaluable patients for ORR will be enrolled in Stage 2. The estimated total enrollment for the trial is 48 patients (assuming a 15% rate of non-evaluable [NE] patients for response).
The trial will consist of the following periods/visits: Screening (Step 1: Confirm ECD-EGFR mutation, Step 2: Full eligibility assessment), Treatment Period, End-of-Treatment Visit, End-of-Trial Visit, and a Safety Follow-up Period.
All patients will receive a loading dose of 9 mg/kg Sym004 maximum 14 days after completed Screening (Step 2) followed by 6 mg/kg weekly (q1w) infusions. Patients will receive mandatory prophylactic treatments for prevention of skin toxicities and infusion related reactions during treatment.
Pre-defined treatment rules apply in case of Sym004 induced skin toxicities and hypomagnesemia. Individual Sym004 dose adjustment in accordance with pre-defined dose modification rules applies in case of Grade 3 anti-EGFR associated skin toxicity and other safety events.
The individual treatment duration is until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from Investigational Medicinal Product (IMP) and/or the trial, or termination of entire trial occurs.
The End-of-Treatment visit will be completed within 10 days after the last dose of IMP and the End-of-Trial Visit will occur no earlier than 28 days after IMP discontinuation.
During the Safety Follow-up period, information on disease progression, subsequent anti-cancer treatment, and survival will be collected every 6 weeks (q6w).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Metastatic Colorectal Cancer
University of California Los Angeles, Ronald Reagan UCLA Medical Center
Not yet recruiting
Published on BioPortfolio: 2016-11-17T11:38:21-0500
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Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.
A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
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Monoclonal antibodies MAbs
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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...