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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07384715 | First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS) | PHASE1 | RECRUITING | 78 | — | — | Feb 16, 2026 | Apr 20, 2030 | Jun 2, 2026 | 9 | Denmark, Germany +1 |
| Arm | Type | Description |
|---|---|---|
| GEN3018 | EXPERIMENTAL | Participants will receive escalating doses of GEN3018 in Part 1 (Dose Escalation). In Part 2 (Dose Refinement), additional participants may be enrolled to evaluate the safety and preliminary efficacy data of the recommended Part 2 dose(s) as determined from the Part 1 Dose Escalation. |
| Name | Type | Description |
|---|---|---|
| GEN3018 | BIOLOGICAL | Intravenous (IV) infusion. |
Key Inclusion Criteria: All Participants: * Be at least 18 years of age at the time of signing informed consent form (ICF). * Participant's life expectancy at screening is judged to be at least 3 months. * Must have fresh bone marrow samples collected at screening. * Bone marrow (BM) blasts ≥ 5% a...