Therapy Detail

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Therapy Name Ublituximab + Umbralisib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ublituximab LFB-R603|TG-1101|TG-20|TGTX-1101 CD20 Antibody 21 Ublituximab (TG-1101) is a monoclonal antibody that targets CD20 that may induce complement-dependent and antibody-dependent cell-mediated cytotoxicity against B-cells expressing CD20, potentially resulting in increased B-cell death (PMID: 23611989, PMID: 32351164).
Umbralisib Ukoniq RP5264|TGR-1202 PIK3CD inhibitor 27 Ukoniq (umbralisib) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513), PMID: 30709431). Ukoniq (umbralisib) is FDA approved for use in adult patients with relapsed or refractory marginal zone lymphoma with one or more prior anti-CD20-based therapy, and in adult patients with relapsed or refractory follicular lymphoma who have three or more prior lines of therapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02006485 Phase I Ublituximab + Umbralisib Ibrutinib Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies Completed USA 0
NCT02793583 Phase II Umbralisib Ublituximab + Umbralisib Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma (UNITY-DLBCL) Terminated USA | ITA | GBR | ESP | AUS 4
NCT03207256 Phase II Ublituximab + Umbralisib Umbralisib Compassionate Use Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials Terminated USA 0
NCT02656303 Phase II Ublituximab + Umbralisib An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304 Terminated USA | ITA | GBR 1
NCT03828448 Phase II Ublituximab + Umbralisib Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naive Follicular Lymphoma Terminated USA 0
NCT04149821 Phase II Ublituximab + Umbralisib Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy Terminated USA 0
NCT04508647 Phase II Ublituximab Ublituximab + Umbralisib Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma Completed USA 0


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