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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06607549 | Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR) | PHASE1 | RECRUITING | 12 | — | — | Mar 18, 2025 | Nov 1, 2030 | Dec 3, 2025 | 1 | United States |
Maximum Tolerated Dose (MTD): MTD is defined as the highest dose under consideration that has an estimated DLT probability below 25% based upon the Bayesian optimal interval design. The MTD will be decided based on the BOIN decision rules set for phase 1a portion of the study.
| Arm | Type | Description |
|---|---|---|
| Treatment: All Patients | EXPERIMENTAL | This study has two main goals: Goal 1: The study will investigate the safety and tolerability of loncastuximab tesirine and rituximab (lonca-R). Goal 2: The study will determine the maximum tolerated dose of lonca-R. |
| Name | Type | Description |
|---|---|---|
| Loncastuximab tesirine and rituximab (Lonca-R) | DRUG | Patients will receive stereotactic radiosurgery (SRS) followed by a brain MRI approx. 3 weeks after SRS. This will be followed by loncastuximab tesirine and rituximab administered intravenously for a total of 6 cycles (every 21 days). |
Inclusion Criteria: * Participant aged ≥ 18 years * ECOG Performance Status ≤ 3 * Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either: * Relapsed or refractory disease with at least 1 prior therapy OR * Ineligible fo...