Title: Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

Principal Investigator: Constantine S. Tam, MD

Description:

Investigators will study the pharmacokinetic and pharmacodynamic profile of TG-1701, an irreversible Bruton tyrosine kinase (BTK) inhibitor, in approximately 50 adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or B-cell lymphoma.1


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In the international trial (NCT03671590), which is currently recruiting adults with histologically confirmed disease, an Eastern Cooperative Oncology Group (ECOG) score from 0 to 2, and adequate organ function, investigators will compare the safety and efficacy of TG-1701 monotherapy with a triplet regimen consisting of TG-1701, umbralisib, and ublituximab. Exclusion criteria include receipt of prior BTK inhibitor therapy; major surgery, chemotherapy, or immunotherapy received within the past 21 days; and known hepatitis B or C virus or HIV infection.

The study’s primary outcome is determining the maximum tolerated dose. The secondary end point is overall response rate.

TG-1701 is an oral BTK inhibitor administered once daily. The investigational agent, highly specific to BTK, has improved selectivity compared with ibrutinib, a first-in-class BTK blocker.2

References

  1. Clinicaltrials.gov. Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies. NCT03671590. Accessed February 19, 2021. https://www.clinicaltrials.gov/ct2/show/NCT03671590?term=TG-1701&draw=2&rank=1
  2. Ribeiro ML, Armengol M, Vinyoles M, et al. TG-1701, a novel irreversible Bruton’s tyrosine kinase inhibitor (BTK), cooperates with ublituximab-driven ADCC and ADCP in in vitro and in vivo models of ibrutinib-resistant mantle cell lymphoma. Poster presented at: 2020 American Association for Cancer Research Annual Meeting; April 24-29. P2205.