CLINICAL TRIALS PROFILE FOR ASTX660
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Clinical Trials for ASTX660
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02503423 ↗ | Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas | Recruiting | Astex Pharmaceuticals | Phase 1/Phase 2 | 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. |
| NCT02503423 ↗ | Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas | Recruiting | Astex Pharmaceuticals, Inc. | Phase 1/Phase 2 | 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. |
| NCT04155580 ↗ | A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) | Recruiting | Astex Pharmaceuticals, Inc. | Phase 1 | To evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months. |
| NCT04362007 ↗ | A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma | Recruiting | Otsuka Pharmaceutical Co., Ltd. | Phase 1/Phase 2 | Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2. Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL. Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL. |
| NCT04411030 ↗ | A Study to Investigate the Effect of CYP3A4 Inhibition on the Single Dose Pharmacokinetics of ASTX660 and the Effect of a Single Dose of ASTX660 on the Pharmacokinetics of the CYP3A4 Substrate Midazolam | Completed | Astex Pharmaceuticals, Inc. | Phase 1 | In Part 1, the primary objective is to investigate the effect of multiple doses of itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of ASTX660. In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy midazolam. Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4 substrate midazolam will also be evaluated. |
| NCT04479800 ↗ | Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers | Completed | Astex Pharmaceuticals, Inc. | Phase 1 | This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions. |
| NCT05082259 ↗ | ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab | Not yet recruiting | Astex Pharmaceuticals, Inc. | Phase 1 | This is a multi-centre Phase I dose finding and proof-of-concept study of the combination of ASTX660 together with Pembrolizumab with expansion cohorts testing preliminary efficacy in immune-refractory cancers, triple negative breast cancer (TNBC), cervical cancer, and glioblastoma. In contrast to the existing studies combining first-generation cIAP1/2 selective Smac mimetics with immune check point inhibitors, the ASTEROID Phase I clinical trial will be the first trial utilising triple cIAP1/2 and XIAP blockade by ASTX660 as a strategy to maximise immunogenic cell death and the generation of an efficient adaptive immune response. ASTX660 is not simply being used to repeat the data already being acquired with other first generation Smac mimetics. In contrast, we will investigate more in depth the mechanisms by which ASTX660 elicits its therapeutic effects both on tumour and on the host immune system. This will be critical to determine the best strategy to pursue in future later stage tumour specific trials of IAP antagonists in combination with immunotherapy, and to ensure appropriate molecular stratification biomarkers for the greatest benefit to patients. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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