L19TNFα in Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01253837|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : September 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Colorectal Cancer||Drug: L19TNFa||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of the Tumor-targeting Human L19TNFα Monoclonal Antibody-cytokine Fusion Protein in Patients With Advanced Solid Tumors|
|Study Start Date :||September 2007|
|Primary Completion Date :||May 2011|
|Study Completion Date :||September 2011|
Phase I: Prospective, open-label, dose escalation study.
Phase II: Prospective, single-arm, open-label study, equivalent to the stage 1 of the Simon two-stage phase II design.
Phase I: Sequential assignment of Patient cohorts to one of six dose levels of L19TNFa: 1.3, 2.6, 5.2, 7.8, 10.4, 13.0 µg/kg.
Phase II: The Recommended Dose (RD) of 13.0 µg/kg of L19TNFα determined in Phase I.
Schedule: Infusions of L19TNFα on days 1, 3 and 5 of each 21-day cycle. Patients may remain on treatment for a maximum of six 21-day cycles.
- Phase I: Determination of the Maximum Tolerated Dose (MTD) and Recommended Dose (RD) [ Time Frame: day 1-29 ]Determination of the Maximum Tolerated Dose (MTD) and Recommended Dose (RD) of L19TNFα.
- Phase II: Investigation of the anti-cancer activity of L19TNFα as measured by Objective Response Rate (ORR) [ Time Frame: within day 42 ]Investigation of the anti-cancer activity of L19TNFα as monotherapy as measured by the Objective Response Rate (ORR) at the end of cycle 2 in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer not amenable to standard systemic therapy.
- Investigation of serum concentrations of L19TNFα (pharmacokinetic properties) [ Time Frame: day 1-5 ]
- Investigation of the induction of human anti-fusion protein antibody (HAFA) [ Time Frame: 1-16 months ]
- Investigation of early signs of anti-tumor activity of L19TNFα [ Time Frame: 14 months ]Investigation of early signs of anti-tumor activity of L19TNFα as measured by Objective Response Rate (ORR) at the end of cycle 2, median Progression-Free Survival (PFS) and median Overall Survival (OS).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253837
|A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - ANCONA (Italy)|
|European Istitue of Oncology Milan (Italy)|
|Principal Investigator:||Filippo De Braud, Dr.||European Istitute of Oncology Milan (Italy)|