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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07123454 | A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma | PHASE1 | RECRUITING | 91 | — | — | Sep 24, 2025 | Mar 1, 2028 | May 8, 2026 | 22 | United States, Australia +6 |
To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
| Arm | Type | Description |
|---|---|---|
| Module 1: AZD4512 Monotherapy dose escalation + backfill | EXPERIMENTAL | In Mod 1, the efficacy and safety of AZD4512 will be evaluated in R/R B-NHL. Module 1 will consist of both dose escalation and Pharmacodynamic/safety backfills which may be used to support MTD and/or Optimal biological dose (OBD) |
| Name | Type | Description |
|---|---|---|
| AZD4512 | DRUG | AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion |
Key Inclusion Criteria: * Eligible patients must be adults (≥18 years) * Documented diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2021 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill p...