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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07509151 | Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV) | PHASE3 | RECRUITING | 420 | — | — | May 5, 2026 | Apr 5, 2032 | Jun 1, 2026 | 30 | Australia, Canada +2 |
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC).
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
| Arm | Type | Description |
|---|---|---|
| Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1 | EXPERIMENTAL | Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length). |
| DOSRI-Surovatamig Dose 2 | EXPERIMENTAL | Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length). |
| Phase III-Arm A: Surovatamig SC | EXPERIMENTAL | Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length). |
| Phase III-Arm B: Observation | NO_INTERVENTION | Participants will undergo observation for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Surovatamig | DRUG | Surovatamig will be administered as a subcutaneous injection. |
Inclusion Criteria: * Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV. * Treatment received and response at the end of 1L (first-line) finite therapy. * Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) wi...