japanese phase 1 trial of sym004 in solid tumors

Conditions: 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 criteria:
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

Keywords: solid tumors sym004 phase 1