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COMPLETED
NCT04174716
PHASE1/PHASE2

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

Sponsor: Idience Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2019-11-06

Completion Date

2024-06-28

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

DRUG

IDX-1197

Until progression or unacceptable toxicity develops

Locations (19)

National Cancer Centre

Goyang, Gyeongggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Inje University Haeundae Hospital

Busan, South Korea

Dong-a University Hospital

Busan, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Cha University Bundang Medical Center

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea