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Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53

NCT03975387 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-04-09

No results posted yet for this study

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

DRUG

ASTX295

ASTX295 orally for 28-day cycle continuous or on an intermittent dosing schedule.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2023-09-11
Completion
2024-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975387 on ClinicalTrials.gov