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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDX-1197 | Experimental | Patient will be receive IDX-1197HCl once daily for 28 continuous days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX-1197 | Drug | Until progression or unacceptable toxicity develops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre | Goyang | Gyeongggi-do | 10408 | South Korea | ||
| Seoul National University Bundang Hospital |
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| Seongnam-si |
| Gyeonggi-do |
| 13620 |
| South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do | 52727 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | 58128 | South Korea |
| Inje University Haeundae Hospital | Busan | 48108 | South Korea |
| Dong-a University Hospital | Busan | 49201 | South Korea |
| Pusan National University Yangsan Hospital | Busan | 50612 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Cha University Bundang Medical Center | Seongnam-si | 13496 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | 07061 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |