Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
Skin Cancer (Non-Melanoma)
18 Years and older, Male and Female
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.
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
according to standard Response Evaluation Criteria in Solid Tumors (RECIST v1.1) using
computed tomography (CT) or magnetic resonance imaging (MRI) scans or assessed using another
reliable method of disease evaluation appropriate for the tumor type.
Treatment Sites in Georgia
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