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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04023526 | A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy | PHASE2 | ACTIVE NOT_RECRUITING | 103 | — | — | Jul 29, 2019 | May 15, 2026 | Aug 20, 2025 | 56 | Australia, Brazil +7 |
| NCT04241549 | A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment | PHASE1 | COMPLETED | 6 | — | — | Mar 25, 2020 | Jul 19, 2021 | Aug 9, 2023 | 5 | Japan |
| NCT04150887 | Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia | PHASE1 | ACTIVE NOT_RECRUITING | 61 | — | — | Dec 23, 2019 | May 15, 2026 | Apr 17, 2025 | 23 | United States, Canada +3 |
Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L
Number of participants with AEs and SAEs will be reported.
Number of participants with DLTs will be reported.
Severity of DLT as assessed by NCI-CTCAE in participants will be reported.
Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported.
| Arm | Type | Description |
|---|---|---|
| Azacitidine 75 mg/m^2 and Cusatuzumab 10 mg/kg | EXPERIMENTAL | Participants will receive azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee. |
| Azacitidine 75 mg/m^2 and Cusatuzumab 20 mg/kg | EXPERIMENTAL | Participants will receive azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee. |
| Part 1 (Dose Finding): Cusatuzumab + Azacitidine | EXPERIMENTAL | Participants with acute myeloid leukemia (AML) will receive cusatuzumab intravenously (IV) in combination with azacitidine subcutaneously (SC) or IV. The dose levels will be escalated based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
| Part 2 (Dose Expansion): Cusatuzumab + Azacitidine | EXPERIMENTAL | Participants with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) will receive cusatuzumab intravenously (IV) at the recommended Phase 2 dose (RP2D) determined in Part 1 in combination with azacitidine subcutaneously (SC) or IV. |
| Experimental: Cohort 2: Cusatuzumab + Venetoclax | EXPERIMENTAL | Participants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US. |
| Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA) | EXPERIMENTAL | Participants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). |
| Name | Type | Description |
|---|---|---|
| Azacitidine | DRUG | Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle. |
| Cusatuzumab | DRUG | Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle. |
| Venetoclax | DRUG | Venetoclax will be administered orally and the dose will ramp-up to 400 mg. |
Inclusion Criteria: * Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines those who are "not candidates for intensive chemotherapy": 1. greater than or equal to (\>=)75 years of age or 2. less than (\...