Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01569412|
Recruitment Status : Terminated
First Posted : April 3, 2012
Last Update Posted : May 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Her2/Neu Positive Advanced Solid Tumors||Biological: Ertumaxomab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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
- maximum tolerated dose [ Time Frame: every week until end of treatment (max. 108 days) ]
- Pharmacodynamic [ Time Frame: weekly until end of treatment (max. 108 days) ]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 ]
- adverse events [ Time Frame: weekly (max 108 days) ]incidence and intensity of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569412
|Frankfurt/Main, Germany, 60488|
|Principal Investigator:||Salah-Eddin Al-Batran, MD||Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany|