Actuate 1901: 9-ING-41 in Myelofibrosis

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT04218071
Trial Phases:	Phase II	Protocol IDs:	1901 (primary) NCI-2020-01824
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Actuate Therapeutics Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04218071

Summary

9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has
both pre-clinical anti-fibrotic activity and activity against myelofibrosis. This Phase 2
study will study its efficacy in patients with advanced myelofibrosis.

Objectives

9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small
molecule, potent selective GSK-3ß inhibitor with significant pre-clinical and clinical
anticancer activity. In the ongoing Actuate 1801 study in a cohort of over 90 patients
with advanced refractory malignancies, 9-ING-41 has exhibited no significant toxicity,
including no myelosuppression, and significant anti-tumor activity. 9-ING-41 also has
significant pre-clinical ability to reverse pathologic fibrosis in multiple models of
pulmonary and pleural fibrosis. Reversal of fibrosis by an anti-fibrotic agent in
patients with advanced myelofibrosis (MF) has recently been demonstrated to be of
clinical benefit. 9-ING-41 has the potential to act both as an anti-neoplastic agent
(without causing myelosuppression) and an anti-fibrotic agent in patients with MF. The
efficacy of Ruxolitinib is limited in many patients by the inability to tolerate adequate
doses for an adequate duration with myelosuppression being a frequent dose limiting
toxicity. 9-ING-41 may reduce the dose of Ruxolitinib needed for optimal therapeutic
response and/or reverse myelosuppression so than an adequate dose of Ruxolitinib can be
tolerated. Pre-clinical data show synergy in MF between 9-ING-41 and Ruxolitinib. This
Phase 2 study is designed to evaluate the efficacy of 9-ING-41, as a single agent or in
combination with Ruxolitinib, in patients with advanced, poor prognosis MF.

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