Print  |  Close

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.