Loading clinical trials...

9-ING-41 in Pediatric Patients With Refractory Malignancies. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

Phase 1 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, as a Single Agent or With Irinotecan, Irinotecan Plus Temozolomide, or With Cyclophosphamide Plus Topotecan in Pediatric Patients With Refractory Malignancies.

NCT04239092•Actuate Therapeutics Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

0 - 22 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet ALL the following criteria to be eligible for this study:
•1. Age \< 22 years of age
•2. Diagnosis of recurrent or refractory malignancy with histologic verification of malignancy at original diagnosis or relapse, except patients with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta-HCG, and/or patients with intrinsic brain stem tumors or patients with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG.
•3. Have either measurable or evaluable disease. Evaluable disease is defined as an assessment of tumor that cannot be measured using a ruler or calipers, but can be used to determine disease progression or response (e.g., positive lesions on MIBG or bone scan, metastatic bone marrow disease, elevated tumor markers, or presence of a malignant pleural effusion)
•4. Have current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
•5. Have Performance Level: Karnofsky ≥ 50% for patients \>16 years of age and Lansky ≥50 for patients ≤16 years of age
•6. Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients with CNS tumors who are receiving steroids must be on a stable or decreasing dose for at least 7 days prior to study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
•7. Have fully recovered from the acute clinically significant toxic effects of prior anti-cancer therapy
•* Myelosuppressive chemotherapy: On first day of treatment be at least 7 days after the last dose of myelosuppressive chemotherapy for single agent 9 ING 41, at least 21 days after the last dose of myelosuppressive chemotherapy for 9-ING-41 plus irinotecan
•* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor or 7 days for short-acting growth factor
+24 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from trial entry:
•1. Has hypersensitivity to any of the components of 9-ING-41 and/or Irinotecan or to the excipients used in their formulation
•2. Has uncontrolled concurrent illness that would limit compliance with study requirements
•3. Has clinically significant retinal disease
•4. Has current malignancy other than the target malignancy with the exception of surgically treated local tumors or is currently receiving other anti-cancer therapies, including radiation.
•5. Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, infertility and ototoxicity. Recovery is defined as ≤ Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)
•6. Is pregnant or lactating
•7. Has received a prior solid organ transplantation
•8. Is receiving any other investigational medicinal product or participating in another interventional clinical trial

Locations (9)

University of California, San Francisco

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Mott Children's Hospital

Ann Arbor, Michigan, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Duke Children's Hospital and Health Center, Duke University Medical Center

Durham, North Carolina, United States

Brown University

Providence, Rhode Island, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Key Dates

Start Date

June 5, 2020

Primary Completion Date

July 7, 2025

Completion Date

July 7, 2025

Last Updated

July 17, 2025

Enrollment

ACTUAL participants

Conditions

Refractory CancerRefractory NeoplasmCancer PediatricRefractory TumorPediatric CancerPediatric Brain TumorNeuroblastomaNeuroblastoma RecurrentPediatric LymphomaPediatric MeningiomaDiffuse Intrinsic Pontine Glioma

Interventions

9-ING-41

DRUG

Irinotecan

DRUG

Temozolomide

DRUG

Cyclophosphamide

DRUG

Topotecan

DRUG

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

NCT05864144

Solid Tumor, AdultAdvanced Solid Tumor+20 more

View study

TERMINATEDPHASE1

Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers

NCT03912831

Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Sapanisertib and Metformin in Treating Patients With Advanced or Metastatic Relapsed or Refractory Cancers

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors