Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

Phase 1

• Conditions: Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies and Documented Mutation of Extra Cellular Doman of EGFR; MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000621-39-ES
• Lead Sponsor: Symphogen A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Written informed consent obtained before undergoing any study-related activities
• Male or female, at least 18 years of age
• Histologically or cytologically confirmed locally advanced or metastatic CRC that is documented to be without KRAS or NRAS gene mutations (i.e. tumors must express the KRAS and NRAS wild type (WT) exon 2, 3, and 4)
• Identification of any ECD-EGFR mutation in blood sample
• Failure of or intolerance to all of the following
a. Fluorouracil (5-FU)
b. Oxaliplatin
c. Irinotecan
• Previous treatment with bevacizumab and/or ziv-aflibercept is allowed, but not mandatory.
• Acquired resistance” to marketed anti-EGFR mAbs
a. Response while on previous treatment with marketed anti-EGFR mAb, defined as
i. Partial response (PR) or complete response (CR) and/or
ii. Stable disease (SD) for more than 16 weeks
b. Documented progressive disease (PD) during or within 3 calendar months after cessation of previous anti-EGFR mAb treatment
• No more than 3 calendar months from last dose of previous anti-EGFR mAb to time of consent
• Measurable disease defined as one or more target lesions according to RECIST 1.1
• Life expectancy of at least 3 months
• ECOG PS = 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

• Intake of any investigational drug or any anticancer therapy in the 28 days (or 5 half-lives for noncytotoxics, whichever is shorter) before the first dose of IMP
• Previous treatment with Sym004, TAS-102 (trifluridine and tipiracil [Lonsurf®]) and/or regorafenib [Stivarga®]
• Patients who in the opinion of the Investigator would benefit more from regorafenib or Lonsurf® treatment (except where regorafenib or Lonsurf® are not reimbursed in the country)
• Diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade >1 at Screening (Step 1)
• Skin rash CTCAE Grade >1 from previous anti-EGFR therapy at Screening (Step 1)
• Magnesium <0.9 mg/dL
• Abnormal organ or bone marrow function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified