On June 5, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital in Paris discussed the protocol of the ongoing first in human study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL) in a "Trial in progress" poster at the 2016 ASCO (Free ASCO Whitepaper) annual meeting (June 3-7, 2016, in Chicago, USA) (Press release, Innate Pharma, JUN 5, 2016, http://innate-pharma.com/en/news-events/asco-2016-phase-i-study-protocol-investigating-iph4102-cutaneous-t-cell-lymphomas [SID:1234513022]).
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The poster has been made available on the Company’s website, in the Product Pipeline – IPH4102 section.
About IPH4102 Phase I trial:
The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:
A dose-escalation part including approximately 40 CTCL patients in 10 dose levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. Cohort design (CTCL subtype, number of patients…) may be revisited based on the findings in the dose escalation part of the study.
The primary objective of this trial is to evaluate the safety and tolerability of repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.
This trial is expected to deliver data for the dose escalation and cohort expansion at the end of 2017 and 2018 respectively.