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476 First-in-human phase 1/2 study of the first-in-class SUMO-activating enzyme inhibitor TAK-981 in patients with advanced or metastatic solid tumors or relapsed/refractory lymphoma: phase 1 results by Arkadiusz Dudek; Dejan Juric; Afshin Dowlati; Ulka Vaishampayan; Hadeel Assad; Jordi Rodón; Bo Chao; Bingxia Wang; John Gibbs; Vaishali Shinde; Sharon Friedlander; Allison Berger; Christine Ward; Alonzo Martinez; Robert Gharavi; Alejandro Gomez-Pinillos; Igor Proscurshim; Anthony Olszanski is a Medicine article available to read on EtoBox.

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## Background SUMOylation is a post-translational modification that serves as an important modulator of immune responses via its role in constraining the type I interferon (IFN-1) response. TAK-981 is a small molecule that inhibits SUMOylation and increases IFN-1-dependent innate immune responses with the potential to enhance adaptive immunity. Here, we report dose-escalation data from a TAK-981 Phase 1/2 clinical study (NCT03648372), the first clinical data for a SUMOylation inhibitor. ## Methods Adults with advanced/metastatic solid tumors or relapsed/refractory lymphomas received TAK-981 IV twice-weekly (BIW; days 1, 4, 8, 11) or once-weekly (QW; days 1, 8) in 21-day cycles. Dose escalation was guided by a Bayesian Logistic Regression Model (BLRM) with overdose control, plus available pharmacokinetic/pharmacodynamic (PK/PD) data. Phase 1 objectives were to determine TAK-981 safety/tolerability and establish the recommended phase 2 dose (RP2D). ## Results Seventy-six patients received TAK-981 at 10 dose levels (3–40 mg BIW; 60–120 mg QW/BIW). Median age was 61 years (range, 38–79); 42 (55.3%) patients were female. Four dose-limiting toxicities were seen in 62 evaluable patients (

Who reads 476 First-in-human phase 1/2 study of the first-in-class SUMO-activating enzyme inhibitor TAK-981 in patients with advanced or metastatic solid tumors or relapsed/refractory lymphoma: phase 1 results?

Author

Arkadiusz Dudek; Dejan Juric; Afshin Dowlati; Ulka Vaishampayan; Hadeel Assad; Jordi Rodón; Bo Chao; Bingxia Wang; John Gibbs; Vaishali Shinde; Sharon Friedlander; Allison Berger; Christine Ward; Alonzo Martinez; Robert Gharavi; Alejandro Gomez-Pinillos; Igor Proscurshim; Anthony Olszanski

Publisher

BMJ

Published

2021

Language

EN

Field

Medicine (Health Sciences)