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

Official Title

Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumours and Lymphomas

Summary:

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 tumours or lymphoma for whom standard life-prolonging measures are not available.

Trial Description

Primary Outcome:

• Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results
• Efficacy (Phase 2) - antitumour activity assessed by objective response rate (ORR)
• Efficacy (Phase 2) - antitumour activity assessed by disease control rate (DCR)

Secondary Outcome:

• Pharmacokinetic outcome of concentration-time curve (AUC)
• Pharmacokinetic outcome of maximum concentration (Cmax)
• Pharmacokinetic outcome of minimum concentration (Cmin)
• Pharmacokinetic outcome of time to maximum concentration (Tmax)
• Pharmacokinetic outcome of samples over time
• Pharmacokinetic outcome of samples over time
• Pharmacokinetic outcome of analysis of ASTX660 metabolites if applicable
• Duration of antitumour response
• Progression-free survival
• Overall survival
• Assessment of target (cIAP1) engagement

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 tumour growth inhibitory activity in nonclinical models. The Phase 1 portion of the study (completed) will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumour 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.

View this trial on ClinicalTrials.gov