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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.