9-ING-41 in Pediatric Patients With Refractory Malignancies.

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Hematopoietic Malignancies Lymphoma Neuroblastoma	NCT ID:	NCT04239092
Trial Phases:	Phase I	Protocol IDs:	1902 (primary) NCI-2020-04584
Eligibility:	0 - 22 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Actuate Therapeutics Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04239092

Summary

9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult
patients. This Phase 1 study will study its efficacy in paediatric patients with advanced
malignancies.

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. 9-ING-41 is very highly active against neuroblastoma in
diverse pre-clinical models. This Phase 1 study is designed to evaluate the safety and
efficacy of 9-ING-41, as a single agent or in combination with irinitecan, in paediatric
patients with advanced malignancies and thus to establish the recommended Phase 2 dose
(RP2D) for further paediatric patient studies.

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