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Study of ASTX029 in Subjects With Advanced Solid Tumors

NCT03520075 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-07-03

Study results available
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Summary

This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced solid malignancies who are not candidates for approved or available therapies.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

ASTX029

PiB

DRUG

ASTX029

Tablet

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2024-08-01
Completion
2025-03-03
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain
  • United Kingdom

Study Locations

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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 NCT03520075 on ClinicalTrials.gov