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SC-8003, Phase 1 study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) inhibitor, as a single agent or with Irinotecan in pediatric patients with refractory malignancies

SC-8003_9-ING-41

  • Condition(s): Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Adrenal Tumors, Adrenocortical Carcinoma, Anaplastic Large Cell Lymphoma (ALCL), Atypical Teratoid/Rhabdoid Tumor, Burkitt's Lymphoma, CNS Embryonal Tumors, CNS Germ Cell Tumors, CNS Sarcoma, Choroid Plexus Tumors, Chronic Myelogenous Leukemia (CML), Clear Cell Sarcoma of the Kidney, Craniopharyngioma, Diffuse Intrinsic Pontine Glioma (DIPG), Diffuse Large B-cell Lymphoma (DLBCL), Diffuse Midline Glioma (DMG), Ependymoma, Ewing Sarcoma, Germ Cell Tumors, Glioneuronal and Neuronal Tumors, Hepatoblastoma, Hepatocellular Carcinoma, High-Grade Glioma, Histiocytic Tumors, Hodgkin Lymphoma, Juvenile Xanthogranuloma (JXG), Langerhans Cell Histiocytosis (LCH), Leukemia & Lymphoma, Liver Tumors, Low-Grade Glioma, Lymphoblastic Lymphoma (LBL), Malignant Bone Tumors, Medulloblastoma, Neuroblastoma, Non-Hodgkin Lymphoma (NHL), Non-rhabdomyosarcoma Soft Tissue Sarcomas, Osteosarcoma, Pheochromocytoma, Pilocytic Astrocytoma, Recurrent and/or Refractory, Renal Cell Carcinoma, Renal Tumors, Retinoblastoma, Rhabdoid Tumor of the Kidney, Rhabdomyosarcoma, Soft Tissue Sarcomas, Survivorship, Thyroid Cancer, Wilms Tumor
  • Phase: I
  • Clinicaltrials.gov ID: NCT04239092

What is the goal of the study?

1. To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of 9-ING-41 as a single agent and in combination with Irinotecan in pediatric patients with refractory malignancies. 2. To describe the toxicity profile and DLT of 9-ING-41 as a single agent and in combination with Irinotecan in pediatric patients with refractory malignancies. 3. To characterize the pharmacokinetics of 9-ING-41 as a single agent and in combination with Irinotecan when administered to pediatric patients with refractory malignancies.

Who can participate in the study?

Everyone

Study Team: