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TGR-1202+ brentuximab vedotin

Phase 1

Hodgkin's Lymphoma | Small molecule | Oncology |TG Therapeutics, Inc.|Last Updated: Oct 2, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

TGR-1202+ brentuximab vedotin · 1 trial · 1 indication

Phase 1 1
NCT02164006Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma PatientsHodgkin's Lymphoma
COMPLETED16 Analytics
PHASE1COMPLETED
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose acceptable for participants
21 days (1 cycle of therapy)

To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Endpoints

Overall Response Rate
Up to 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TGR-1202 + brentuximab vedotinEXPERIMENTALTGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin

Interventions

NameTypeDescription
TGR-1202 + brentuximab vedotinDRUGTGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed diagnosis of Hodgkin's Lymphoma * Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion...

Countries:United States
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Frequently asked questions about TGR-1202+ brentuximab vedotin

What is TGR-1202 used for?

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.

What does TGR-1202 target?

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.

Who makes TGR-1202?

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.

What phase is TGR-1202 in?

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.

What clinical trials is TGR-1202 in?

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.

Is TGR-1202 the same as umbralisib?

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.