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Table 3 Clinical trials with non-covalent BTK inhibitors

From: Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies

Non-covalent BTK inhibitor

Phase

Patient population

Strategy

ClinicalTrials.gov ID

Status

Vecabrutinib

I/II dose escalation and expansion trial

CLL/SLL or NHL (including LPL/WM, MCL, MZL, ABC-DLBCL, FL) patients who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication

Monotherapy

NCT03037645

Terminated

ARQ 531

I/II dose escalation and expansion trial

Dose escalation cohorts: R/R CLL/SLL, FL, MCL, MZL, and WM patients who have received ≥ 2 prior systemic therapies; expansion cohorts include R/R CLL/SLL after ≥ 2 prior systemic therapies including a covalent BTKi, with or without a C481 mutation

Monotherapy

NCT03162536

Recruiting

Fenebrutinib

Ia dose escalation trial

R/R NHL (including FL, DLBCL, MCL, PLL/WM) or CLL

Monotherapy

NCT01991184

Active, not recruiting

LOXO-305

I/II dose escalation and expansion trial

CLL/SLL or NHL patients who have failed or are intolerant to standard of care

Monotherapy; combination therapy

NCT03740529

Recruiting

LOXO-305

III

MCL patients who have been previously treated with at least one prior line of systemic therapy and were BTK inhibitor naive

Monotherapy (versus investigator choice of BTK Inhibitor)

NCT04662255

Not yet recruiting

LOXO-305

III

CLL/SLL patients who were previously treated with a covalent BTK inhibitor

Monotherapy (versus idelalisib plus rituximab or bendamustine plus rituximab)

NCT04666038

Not yet recruiting

  1. CLL/SLL chronic lymphocytic leukemia/small lymphocytic lymphoma, NHL non-Hodgkin's lymphoma, LPL lymphoplasmacytic lymphoma, WM Waldenstrom's macroglobulinemia, MCL mantle cell lymphoma, MZL marginal zone lymphoma, DLBCL diffuse large B cell lymphoma, ABC-DLBCL the activated B cell subtype of DLBCL, FL follicular lymphoma, BTK Bruton tyrosine kinase, R/R relapsed and/or refractory, PLL prolymphocytic leukemia