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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...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib |
TG-1801 is an investigational small molecule being developed by TG Therapeutics, Inc. for B-cell lymphoma. It is a bispecific antibody that targets CD47 and CD19. TG-1801 has completed a Phase 1 clinical trial and is not approved for any indication.
TG-1801 is being studied for the treatment of B-cell lymphoma. It was evaluated in a Phase 1 trial in subjects with B-cell lymphoma. As an investigational agent, TG-1801 has not been approved for the treatment of B-cell lymphoma or any other condition.
TG-1801 targets CD47 and CD19. It is a bispecific antibody designed to bind both targets. CD19 is a marker found on B cells, and CD47 is a widely expressed cell surface protein. This dual targeting approach is being explored in B-cell lymphoma.
TG-1801 is being developed by TG Therapeutics, Inc., which trades on the Nasdaq under the ticker TGTX. The company is the sponsor of the clinical program evaluating TG-1801 in B-cell lymphoma.
TG-1801 is in Phase 1 development. Its single clinical trial, NCT03804996, has been completed. The study enrolled 50 participants with B-cell lymphoma and was conducted in Australia. TG-1801 remains investigational and has not received FDA approval.
TG-1801 has been studied in one clinical trial, NCT03804996, titled Study of TG-1801 in Subjects With B-Cell Lymphoma. This Phase 1 trial enrolled 50 participants, was controlled, and has been completed. It was conducted in Australia and included adults aged 18 years and older.