The complete data of tolerance and activity data clinical updates will be presented at the congress of the ICML* 2017 ;
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The part expansion cohort of the trial is in course of preparation.
Innate Pharma SA (Euronext Paris : FR0010331421 IPH) announces today the end of the game by dose escalation of the Phase I trial evaluating IPH4102 in patients with cutaneous T-cell lymphoma (LTC) in relapsed or refractory. No dose-limiting toxicities were observed and the maximum tolerated dose (MTD) was not reached.
The full results of tolerance as well as data of clinical activity updates will be presented in an oral presentation at the congress of the ICML 2017 to Lugano, 14 June at 17: 30 CEST.
The abstract entitled “Phase I study of IPH4102, anti-KIR3DL2 mab, in relapsed/refractory cutaneous T-cell lymphomas (CTCL): dose-escalation safety, biomarker and clinical activity results” will be available on the website of the ICML, June 7.
The extension of the study will begin in the coming weeks. It will include two cohorts each of 15 patients with mycosis fungoides transformed or syndrome of Sézary. Patients will receive IPH4102 at the recommended dose for Phase II (RP2D), until progression.
Pierre Dodion, Medical Director of Innate Pharma, commented : “Although the cutaneous T-cell lymphoma is an indication orphan, the trial has progressed rapidly. We are excited about the safety profile of promising and signals of efficacy of our antibodies in this disease particularly difficult to treat. We are preparing the extension cohort whose launch can be expected soon. We look forward to the return of the regulatory authorities on the data accumulated to this day. ”
About the Phase I trial :
The Phase I study (NCT02593045) is an open-label, multicenter trial testing IPH4102 in patients with a LTC in relapsed or refractory. It is conducted in Europe (France, the netherlands and the United Kingdom) and the United States with the participation of centres of reference : the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, California), the Ohio State University (Columbus, Ohio), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Leiden, the netherlands), and the Guy’s and St Thomas Hospital (London, The United Kingdom).
In total, 55 patients with a LTC advanced and has already received at least two lines of systemic therapy should be enrolled in this study of dose escalation followed by an expansion cohort.
The escalation of dose, which featured 10 levels of doses, has recruited 25 patients with a CTA positive for the target KIR3DL2. The aim of this part was to identify the maximum tolerated dose and/or recommended dose for phase II, dose escalation followed a design of type 3 + 3 accelerated. Preliminary evidence of tolerability and clinical activity for the first seven dose levels were presented to the 3WCCL and ASH 2016.
The expansion cohort will include 2 cohorts of 15 patients with a syndrome of Ctcl or mycosis fungoides transformed. They will receive IPH4102 at the recommended dose, until progression.
The main objective of this trial is to evaluate the tolerability and safety of repeated administration of IPH4102 in this population of patients. The secondary objectives include the evaluation of the anti-tumor activity of the drug candidate. The criteria for assessment of clinical activity include the overall response rate, duration of response and progression-free survival. A large number of exploratory analyses aimed at identifying biomarkers of clinical activity are conducted.
* International Conference On Malignant Lymphoma
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