Solid Tumors Clinical Trial
Official title:
A Japanese Phase I Open-label Dose-escalation Trial of Sym004 Administered as Monotherapy in Japanese Subjects With Advanced Solid Tumors
Verified date | July 2016 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
This is a Phase 1, open-label, dose-escalation trial to assess the safety and tolerability of Sym004, administered weekly or biweekly as monotherapy in Japanese subjects with advanced solid tumors.
Status | Completed |
Enrollment | 51 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Please contact the Merck KGaA Communication Center located in | Darmstadt |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity as determined in Part-A | Up to Week 4 | Yes | |
Primary | Number of subjects with Adverse Events | Up to 4 weeks after the last Sym004 administration | Yes | |
Secondary | Pharmacokinetic profile of Sym004: Area under curve (AUC), Half-life (t1/2 ), Clearance (CL), Volume of distribution at the elimination phase (Vz ), Maximum concentration (Cmax ), Trough concentration (Ctrough), Time to reach Cmax (tmax ) | Up to 8 weeks after the last Sym004 administration | No | |
Secondary | Best overall response rate | Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Duration of overall response | Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Disease control rate | Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Duration of disease control | Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Time to progression | Time from enrollment until the date of objectively documented disease progression, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Progression-free survival time | Time from enrollment until the date of objectively documented disease progression or death, up to 4 weeks after the last Sym004 administration | No | |
Secondary | Change from Baseline in anti-drug antibody (ADA) titer at Weeks 1 and 5 | Baseline, Weeks 1 and 5 | No | |
Secondary | Epidermal growth factor receptor levels in skin tissues | Weeks 1 and 5 | No |
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