NCT04174716

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

An Open-label, Multi-center, Phase 1b/2a Basket Trial of IDX-1197 in Patients With Homologous Recombination Repair Mutated Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Idience Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	IDX-1197	Until progression or unacceptable toxicity develops

Timeline

• Start date: 2019-11-06
• Primary completion: 2023-03-31
• Completion: 2024-06-28
• First posted: 2019-11-22
• Last updated: 2026-04-17

Locations

19 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study