Trials / Terminated
TerminatedNCT03975387
Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53
Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects With Wild-Type TP53 Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Taiho Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in participants with wild-type TP53 advanced solid tumors. Phase 1 is a dose escalation and dose expansion study design. Sponsor made the strategic decision to not pursue the Phase 2 part of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASTX295 | ASTX295 orally for 28-day cycle continuous or on an intermittent dosing schedule. |
Timeline
- Start date
- 2019-07-11
- Primary completion
- 2023-09-11
- Completion
- 2024-08-15
- First posted
- 2019-06-05
- Last updated
- 2025-04-09
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03975387. Inclusion in this directory is not an endorsement.