Sym004 in Patients With Advanced Solid Tumors
This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts. Part A investigates the safety and PK of escalating weekly dosing of Sym004 in patients with recurrent advanced solid tumors. Part B and C validates the safety, PK and efficacy of weekly dosing of Sym004 at the MTD in a homogenous patient population with advanced mCRC and wild-type KRAS. If MTD equals 12 mg/kg, then part C will explore the 9 mg/kg level. Part B will be initiated when a safe dose has been established in Part A. Part D and E is to validate the safety, PK and efficacy when administered every 2 weeks at doses of 12 mg/kg and 18 mg/kg, respectively.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Multi-center Phase I Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Sym004 in Patients With Advanced Solid Tumors|
- Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]DLTs (DLT period of 4 weeks after first dose in each patient) along with; incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during the entire trial period.
- Objective tumor response according to RECIST criteria verified by imaging techniques [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Duration of overall response [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Host immune response: ADA monitoring [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Skin rash according to CTCAE grading [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Biomarker including CEA and YKL 40 [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Vital signs and laboratory parameters [ Time Frame: 01/02/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
- Pharmakokinetic profile of multiple weekly and biweekly doses of Sym004 [ Time Frame: 24/08/2010 to 28/02/2014 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression.
In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression.
In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression.
In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression.
Other Name: Sym004
|Contact: Ulla H Hansen, RN||+45 8870 firstname.lastname@example.org|
|Contact: Mimi F Flensburg, DVM PhD||+45 8870 email@example.com|
|United States, Texas|
|South Texas Accelerated Research Therapeutics (START)||Completed|
|San Antonio, Texas, United States, 78229|
|UZ Gasthuisberg, Digestive Oncology Unit||Recruiting|
|Brussel, Belgium, 3000|
|Contact: Eric Van Cutsem, Prof. firstname.lastname@example.org|
|Medical Oncology Department, Vall d´Hebron University Hospital||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Josep Tabernero, MD +34 93 274 6085 email@example.com|
|Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío||Recruiting|
|Sevilla, Spain, 41013|
|Contact: Rocio Garcia Carbonero, Dra. firstname.lastname@example.org|
|Hospital Clínico Universitario de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: Andrés Cervantes, Dr. email@example.com|
|Principal Investigator:||Josep Tabernero, Dr.||Hospital Vall d'Hebron BCN ES|