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TGR-1202 · 3 trials · 12 indications
To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting \>7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting \> 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade \>2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting.
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
| Arm | Type | Description |
|---|---|---|
| CLL | EXPERIMENTAL | Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily. |
| MCL | EXPERIMENTAL | Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily. |
| TGR-1202 | EXPERIMENTAL | TGR-1202 daily dose |
| TGR-1202 + nab-paclitaxel + gemcitabine | EXPERIMENTAL | TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion |
| TGR-1202 + FOLFOX | EXPERIMENTAL | TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) |
| TGR-1202 + FOLFOX + Bevacizumab | EXPERIMENTAL | TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion |
| Name | Type | Description |
|---|---|---|
| TGR-1202 | DRUG | Capsules taken whole daily with water and with food |
| Ibrutinib | DRUG | Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges |
| nab-paclitaxel + gemcitabine | DRUG | IV infusion |
| Oxaliplatin + Folinic acid + Fluorouracil | DRUG | IV infusion |
| Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab | DRUG | IV Infusion |
Inclusion Criteria: * Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL) * Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin, Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine ...
TGR-1202 is an investigational small molecule being studied for the treatment of hematologic malignancies and solid tumors. In clinical trials, it has been evaluated in patients with Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, and Pancreatic Cancer, among other conditions.
TGR-1202 is a PI3K delta inhibitor. It targets the delta isoform of phosphoinositide 3-kinase, an enzyme involved in cell growth and survival that is often overactive in certain cancers. By inhibiting this target, TGR-1202 aims to disrupt cancer cell proliferation.
TGR-1202 is being developed by TG Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TGTX on the NASDAQ exchange.
TGR-1202 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for TGR-1202 were Phase 1 studies, and the drug remains in early-stage clinical testing.
TGR-1202 has been studied in several completed Phase 1 trials. These include NCT01767766 in relapsed or refractory hematologic malignancies, NCT02164006 in combination with brentuximab vedotin for Hodgkin's Lymphoma, NCT02268851 with ibrutinib in CLL or MCL, and NCT02574663 in solid tumors.
Yes, TGR-1202 is also known as umbralisib. The drug has been referred to by both names in clinical research and development contexts. This alternative name is used interchangeably with TGR-1202 in scientific literature and trial documentation.