Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small molecule, potent selective GSK-3β 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04239092
Study type Interventional
Source Actuate Therapeutics Inc.
Contact Andrew P Mazar, PhD
Phone (858) 922-6618
Email amazar@actuatetherapeutics.com
Status Recruiting
Phase Phase 1
Start date June 5, 2020
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT00492167 - Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma Phase 1
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Active, not recruiting NCT03107988 - NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) Phase 1
Recruiting NCT04253015 - A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT00588068 - Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Recruiting NCT04301843 - Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Phase 2
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Recruiting NCT04040088 - An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors Early Phase 1
Recruiting NCT06057948 - A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma Phase 2
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Recruiting NCT02559778 - Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Phase 2
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02245997 - Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma N/A
Not yet recruiting NCT01156350 - Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma Phase 2
Active, not recruiting NCT01192555 - Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma Phase 1/Phase 2
Completed NCT01222780 - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer Phase 1