9-ING-41 in Pediatric Patients With Refractory Malignancies.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer Pediatric
- Diffuse Intrinsic Pontine Glioma
- Neuroblastoma
- Neuroblastoma Recurrent
- Pediatric Brain Tumor
- Pediatric Cancer
- Pediatric Lymphoma
- Pediatric Meningioma
- Refractory Cancer
- Refractory Neoplasm
- Refractory Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will receive either single agent 9-ING-41 or 9-ING-41 plus IrinotecanMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 22 years
- Gender
- Both males and females
Description
9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small molecule, potent selective GSK-3? 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-...
9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small molecule, potent selective GSK-3? 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.
Tracking Information
- NCT #
- NCT04239092
- Collaborators
- Developmental Therapeutics Consortium
- Investigators
- Study Director: Ludimila Cavalcante, MD Actuate Therapeutics
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