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CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

NCT04870944 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-05-05

No results posted yet for this study

Summary

This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.

Conditions

  • Diffuse Midline Glioma, H3 K27-Altered
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Recurrent Diffuse Intrinsic Pontine Glioma
  • Recurrent Diffuse Midline Glioma, H3 K27-Altered
  • Recurrent Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Primary Malignant Central Nervous System Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Primary Malignant Central Nervous System Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow aspirate

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

FACT Complex-targeting Curaxin CBL0137

Given IV

Sponsors & Collaborators

  • Incuron LLC

    collaborator UNKNOWN

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • David S Ziegler · Pediatric Early Phase Clinical Trial Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870944 on ClinicalTrials.gov