Last updated on July 2018

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

Brief description of study

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

Detailed Study Description

ASTX660 is a synthetic small molecule dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. ASTX660 has not been previously evaluated in human subjects. The Phase 1 portion of the study will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumor types.

Subjects will continue to receive their assigned treatment throughout the study until the occurrence of disease progression, death, or unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Tolerability and safety of study treatment will be evaluated throughout the study by collection of clinical and laboratory data. In Phase 2, antitumor response will be assessed using computed tomography (CT) or magnetic resonance imaging (MRI) scans or other appropriate disease evaluation methods. In subjects with solid tumors, response will be evaluated according to standard Response Evaluation Criteria in Solid Tumors (RECIST v1.1; Appendix 3). In subjects with DLBCL and PTCL, antitumor response will be evaluated according to the 2014 Lugano classification (Appendix 5). In subjects with CTCL, global overall response criteria will be used, based on skin, blood, node, and viscera assessments (Appendix 4).

Clinical Study Identifier: NCT02503423

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