A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Pa
The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
| Condition(s) | Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M. |
| Who can participate | Inclusion Criteria: * For Phase 1-Dose escalation: Relapsed/refractory (R/R) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO) Classification 2022 and relapsed/refractory higher-risk myelodysplastic syndrome (R/R HR -MDS) (includes high- and very high-risk MDS) as confirmed by the Revised International Prognostic Scoring System (IPSS-R) for whom no standard therapy of proven benefit is available. * For Phase1-Dose optimization and Phase 2: R/R AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification 2022 for whom no standard therapy of proven benefit is available. * Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2. * Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Debiopharm International SA |
| Locations | Duarte, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States; Buffalo, New York, United States; Columbus, Ohio, United States (+1 more sites) |
| Start date | 2025-05-30 |
| NCT ID | NCT06969430 |
| Official listing | https://clinicaltrials.gov/study/NCT06969430 |