Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02715011 | Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) | PHASE1 | COMPLETED | 62 | — | — | Jun 1, 2016 | Mar 26, 2021 | Aug 31, 2021 | 10 | United States, Spain |
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-63709178 in Part 1 (in different cohorts). Each subsequent cohort will receive JNJ-63709178 at an increased dose level. Ascending doses may be given initially to minimize or prevent cytokine release syndrome. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase. |
| Name | Type | Description |
|---|---|---|
| JNJ-63709178 | DRUG | Participants will receive JNJ-63709178 in Part 1 and Part 2. |
Inclusion Criteria: * A diagnosis of acute myeloid leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 ...