A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours
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|ClinicalTrials.gov Identifier: NCT01058538|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : February 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumours||Drug: L19IL2||Phase 1 Phase 2|
This is an open-label, non-randomised, multicentre, Phase I/II study to assess safety, pharmacokinetics (PK), and early signs of activity of L19-IL2 monotherapy.
In the first part of the study, there will be 5 dose escalation steps in sequential cohorts of patients with advanced solid tumours. In the second part of the study, patients with advanced RCC will be given a fixed dose of L19IL2 at the RD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||November 2009|
Route: i.v. infusion (60 min) Patients will receive a minimum of 2 cycles of treatment. Each cycle is comprised of treatment on Days 1, 3 and 5 followed by a 16 days rest (1 cycle= 21 days). Patients may receive up to 4 further cycles of treatment (max. of 6 cycles in total). Patients will be initially recruited into the study in cohorts of 3 and the starting dose of L19IL2 will be 5 Mio IU IL2 equivalent. Five steps of dose escalation are planned: 5, 10, 20, 30 and 40 Mio IU IL2 equivalent). After the MTD has been established, the RD will be determined. A further 12 patients (with RCC) will receive the RD dose for a minimum of 2 cycles. For patients in the RD part of the study, patients can switch to maintenance therapy. Maintenance therapy consists of 15 Mio IU IL2 every 2 weeks. The maximum duration of the study for a patient is 12 months.
- To determine the maximum tolerated dose (MTD) and recommended dose (RD) of the human L19IL2 fusion-cytokine. [ Time Frame: 21 days ]
- To determine the pharmacokinetic profile. [ Time Frame: 5 days ]
- To determine the qualitative and quantitative toxicity profile. [ Time Frame: 21 days ]
- To assess the presence of anti-fusion protein antibodies in treated patients. [ Time Frame: 18 weeks ]
- To evaluate the safety profile of repeated administrations of L19IL2 in patients treated at the RD. [ Time Frame: 1 year ]
- To identify early signs of antitumour activity. [ Time Frame: 1 year ]
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): NCT01058538
|Campus Charité Mitte|
|Berlin, Germany, 10117|
|European Institute of Oncology|
|Milan, Italy, 20141|
|Principal Investigator:||Filippo De Braud, Dr||European Institute of Oncology Milan (Italy)|
|Principal Investigator:||Manfred Johannsen, Dr||Champus Charitè Mitte Berlin (Germany)|