Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TG-1801 · 1 trial · 1 indication
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 |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
TG-1801 is an investigational small molecule being studied for the treatment of B-Cell Lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in patients with this type of cancer.
TG-1801 is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TGTX. The company is conducting clinical research to evaluate the drug's potential as a treatment for B-Cell Lymphoma.
TG-1801 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials. The Phase 1 trial has been completed, and the drug remains under investigation for B-Cell Lymphoma.
TG-1801 has one completed clinical trial, identified as NCT03804996, titled "Study of TG-1801 in Subjects With B-Cell Lymphoma." This Phase 1 study enrolled 50 participants in Australia and included adults aged 18 years and older. The trial was controlled but not randomized or double-blinded.
TG-1801 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for B-Cell Lymphoma. The completed Phase 1 trial, NCT03804996, was conducted in Australia, and the drug has not yet progressed to later-stage trials or received marketing authorization.