Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Japanese Phase 1 Trial of Sym004 in Solid Tumors

Summary: This trial is to assess the safety and tolerability of Sym004, administered weekly or biweekly as monotherapy in Japanese subjects with advanced solid tumors.This study consisted of two parts, a dose-escalation part ("Part-A") and a dose-expansion part ("Part-B"). In Part-A, Sym004 will be administered weekly or biweekly as monotherapy in Japanese subjects with advanced solid tumors. In Part-B, Sym004 will be administered weekly as monotherapy to Japanese subjects with advanced esophageal squamous cell carcinoma (ESCC) as dose-expansion. A subject will receive Sym004 administration weekly at a dose that will determined to be the MTD or a dose that will lower than the MTD and determined to be appropriate with recommendation by Safety monitoring committee (SMC). The dose going to used in Part-B will be determined after safety confirmation of weekly regimens in Part-A of this trial.


Eligibility: Inclusion Criteria:
  -  Japanese male or female subjects aged greater than or equal to 20 years at the time of informed consent signature
  -  Histologically or cytologically confirmed cancer
  -  Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Life expectancy of at least 3 months
  -  Written informed consent given before any trial-related activities are carried out
  -  Other protocol defined inclusion criteria could apply
  Exclusion Criteria:
  -  Subjects with symptomatic brain metastases
  -  Subjects who received total resection or irradiation of the target lesion
  -  Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent
  -  Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1
  -  Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)
  -  Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)
  -  Magnesium of less than 0.9 milligram per deciliter (mg/dL)
  -  Abnormal organ or bone marrow function as defined in the protocol
  -  Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1
  -  Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator
  -  Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components
  -  Clinically significant cardiac disease or concurrent, uncontrolled medical condition
  -  Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies
  -  Other protocol defined exclusion criteria could apply

Relevance to patient case: possibly relevant