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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07581002 | A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) | PHASE2 | NOT YET_RECRUITING | 660 | — | — | Jul 22, 2026 | Jun 1, 2032 | May 12, 2026 | - | — |
| NCT07306832 | A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) | PHASE1 | RECRUITING | 18 | — | — | May 20, 2026 | Mar 1, 2030 | Jun 2, 2026 | 5 | United States, Australia +1 |
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
The time (in number of days) from randomization to death due to any cause.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of participants with protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with pivekimab sunirine (PVEK). Severity of TEAEs will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Maximum observed serum/plasma concentration of intact ADC.
Maximum observed serum/plasma concentration of FGN849 payload.
Area under the concentration-time curve of intact ADC.
Area under the concentration-time curve of FGN849 payload.
Time to Cmax of intact ADC.
Time to Cmax of payload.
| Arm | Type | Description |
|---|---|---|
| Phase 2: Arm A - PVEK, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK, VEN, and AZA |
| Phase 2: Arm B - VEN and AZA | ACTIVE_COMPARATOR | Participants will receive VEN and AZA |
| Phase 3: Arm A - PVEK, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK, VEN, and AZA |
| Phase 3: Arm B - PVEK-Placebo, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK-Placebo, VEN, and AZA |
| Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1 |
| Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. |
| Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. |
| Name | Type | Description |
|---|---|---|
| Pivekimab Sunirine | DRUG | Intravenous |
| Venetoclax | DRUG | Orally |
| Azacitidine | DRUG | Intravenous Or Subcutaneous |
| Matching Placebo for PVEK | DRUG | Intravenous |
Inclusion Criteria: 1. Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria with a projected life expectancy of at least 12 weeks. 2. CD123-positive 3. Ineligible for intensive induction...