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Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS)

NCT04174716 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-04-17

No results posted yet for this study

Summary

This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation.

There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.

Conditions

  • Solid Tumors
  • Homologous Recombination Repair Gene Mutation
  • Homologous Recombination Deficiency

Interventions

DRUG

IDX-1197

Until progression or unacceptable toxicity develops

Sponsors & Collaborators

  • Idience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2023-03-31
Completion
2024-06-28
FDA Drug
Yes

Countries

  • South Korea

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 NCT04174716 on ClinicalTrials.gov