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Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS)
Sponsor: Idience Co., Ltd.
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
Conditions
Interventions
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