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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04227847 | A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies | PHASE1 | RECRUITING | 178 | — | — | Aug 7, 2020 | Jul 3, 2028 | Apr 7, 2026 | 54 | United States, Japan +1 |
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS |
| Part B | EXPERIMENTAL | SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS |
| Part C | EXPERIMENTAL | SEA-CD70 expansion cohort in relapsed/refractory AML |
| Part D | EXPERIMENTAL | SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML |
| Part E | EXPERIMENTAL | SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML |
| Part F | EXPERIMENTAL | SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML |
| Part G | EXPERIMENTAL | SEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML |
| Name | Type | Description |
|---|---|---|
| SEA-CD70 | DRUG | Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle |
| azacitidine | DRUG | 75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle. |
| Venetoclax | DRUG | 400 mg /day PO, continuously; administered with ramping |
Part A Inclusion Criteria * Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with * Measurable disease per WHO MDS with excess blasts criteria * MDS that is relapsed or refractory and must not have other therapeutic options * ...