L19TNFα in Patients With Advanced Solid Tumors
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|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|
|Actual Primary Completion Date :||May 2011|
|Actual 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).
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): 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)|