On July 2, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that it plans to launch in the second half of 2020 a new phase Ib / II trial of MEN1611, a potent and selective phosphatidylinositol 3-kinase inhibitor currently under development for the treatment of breast cancer (Press release, Menarini, JUL 2, 2020, View Source [SID1234561659]). The new study, called C-PRECISE-01, will evaluate MEN1611 in combination with cetuximab in patients with mutated pIK3 metastatic colorectal cancer (CRCm) and native RAS / BRAF who have not responded to treatment with irinotecan, oxaliplatin, 5-FU. and regimens containing anti-EGFR.
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The study design will be presented at the ESMO (Free ESMO Whitepaper) 2020 Virtual World Congress on Gastrointestinal Cancer [1-4 July 2020], with the e-poster entitled "C-PRECISE-01 Study: a phase Ib / II trial of MEN1611, a PI3K inhibitor, and cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens. "
MEN1611 is an oral PI3K inhibitor active on p110α, β and γ isoforms, while preserving δ. Preclinical and clinical evidence supports the development of MEN1611 in combination with other agents in the context of solid tumors. the presence of PIK3CA mutations in CRCm has been correlated with a prediction of a negative response to anti-EGFR treatment, making PI3K an attractive therapeutic target. The primary objective of Study C-PRECISE-01 is to determine the recommended phase 2 dose (RP2D) of MEN1611 in combination with cetuximab, and to assess the antitumor activity of MEN1611. Secondary objectives will include evaluation of the safety, tolerability and pharmacokinetic profile of MEN1611 in combination with cetuximab.
Speaking by Andrea Pellacani , CEO of Menarini Ricerche: "Colorectal cancer is among the most prevalent malignancies in the world and there is an urgent need to discover new therapeutic options to help CRC patients, especially those with metastatic lesions. The start of the C-PRECISE-01 trial will give us the possibility to investigate the potential of MEN1611 in a disease with a high medical need, where PIK3CA represents an adequate therapeutic target. This confirms our commitment to advance in precision oncology and develop effective therapeutic alternatives that mean before and after for cancer patients. "