Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors
Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well as efficacy.
Her2/Neu Positive Advanced Solid Tumors
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II, Open Label, Dose Escalating Study To Investigate Safety, Tolerability, And Preliminary Efficacy Of The Trifunctional Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Expressing (1+/SISH Positive, 2+ and 3+) Solid Tumors Progressing After Standard Therapy|
- maximum tolerated dose [ Time Frame: every week until end of treatment (max. 108 days) ] [ Designated as safety issue: Yes ]
- Pharmacodynamic [ Time Frame: weekly until end of treatment (max. 108 days) ] [ Designated as safety issue: Yes ]Determination of HAMA, Serum levels of cytokines IL2, 6, 8, TNF-alpha, IFN-gamma, Blood cell count (immune status), Humoral immune responses (autologous anti-EpCAM / anti-Her2neu antibodies), Identification of T memory cells
- efficacy according to RECIST and immune related response criteria (irRC) [ Time Frame: every 6 weeks until progression of disease ] [ Designated as safety issue: No ]
- adverse events [ Time Frame: weekly (max 108 days) ] [ Designated as safety issue: Yes ]incidence and intensity of adverse events
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Ertumaxomab administration during two treatment cycles will follow a predefined dose escalation scheme, consisting of 5 ascending doses per cycle with each infusion lasting 3 hours.
trifunctional antibody, infusion i.v., increasing doses, up to 10 infusions
This is an open label phase I/II study dose escalating study to investigate safety, tolerability, and preliminary efficacy of the trifunctional anti-HER2/neu x anti-CD3 antibody ertumaxomab in patients with HER2/neu (1+/SISH positive, 2+ and 3+) expressing solid tumors progressing after standard therapy. The primary objectives of the study is to assess the safety and tolerability of ertumaxomab in order to determine the maximum tolerated dose (MTD) and to establish a recommended dose (RD) for further development.
A maximum of ten infusions will be applicated.
Patients will be seen at baseline/screening, and then weekly for infusion and safety assessment with a break of 3 weeks after the 5th dose. Radiological tumor assessment will be performed every 6 weeks. Post-study follow-up will be completed every 8 weeks for up to one year.
|Contact: Salah-Eddin Al-Batran, MDfirstname.lastname@example.org|
|Contact: Claudia Pauligk, PhDemail@example.com|
|Frankfurt/Main, Germany, 60488|
|Contact: Salah-Eddin Al-Batran, MD +496976014420 firstname.lastname@example.org|
|Contact: Claudia Pauligk, PhD +496976013906 email@example.com|
|Principal Investigator: Salah-Eddin Al-Batran, MD|
|Principal Investigator:||Salah-Eddin Al-Batran, MD||Krankenhaus Nordwest|