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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Until progression or unacceptable toxicity develops
National Cancer Centre
Goyang, Gyeongggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
objective response rate (ORR)
Confirmed objective response rate (ORR) determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1).
Time frame: Up to 24 weeks
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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
...and 9 more locations