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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03804996 | Study of TG-1801 in Subjects With B-Cell Lymphoma | PHASE1 | COMPLETED | 50 | — | — | Mar 5, 2019 | Feb 21, 2024 | Apr 8, 2024 | 3 | Australia |
To determine the recommended Phase 2 dose (RP2D) by identifying dose limiting toxicity (DLT), maximum tolerable dose (MTD), and optimum biologic dose (OBD).
To characterize the safety profile of TG-1801 alone and in combination with ublituximab by evaluating the adverse event profile.
| Arm | Type | Description |
|---|---|---|
| TG-1801 | EXPERIMENTAL | Arm Description: TG-1801 will be administered once every 4 weeks (28-day) cycles. Subjects who experience disease progression after completing 6 months of single agent TG-1801 will be eligible for TG-1801 single-agent re-treatment at the discretion of the investigator. |
| TG-1101 | EXPERIMENTAL | Arm Description: TG-1801 and ublituximab will be administered once every 4 weeks (28-day cycle) for up to 6 cycles followed by TG-1801 monotherapy. To explore the safety of TG-1801 in combination with ublituximab will be explored at doses below and up to the RP2D. TG-1801 intrapatient dose escalation will not be permitted in combination therapy. |
| Name | Type | Description |
|---|---|---|
| TG-1801 | DRUG | Intravenous infusion over 1 hour every 4 weeks |
| Ublituximab | BIOLOGICAL | "recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks" |
Inclusion Criteria: 1. Histologically confirmed B-cell lymphoma, relapsed to or refractory after at least one prior standard therapy. For subjects with aggressive lymphoma: those who are non-candidates for high-dose therapy or autologous stem cell transplant. Refractory is defined as disease progre...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Soligenix, Inc. | SNGX | 1 | PHASE3 | Hypericin |
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | — | Undisclosed |