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Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

NCT04541082 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-12-18

No results posted yet for this study

Summary

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.

Conditions

  • Central Nervous System Neoplasms
  • Glioblastoma
  • Gliosarcoma, Adult
  • Anaplastic Oligodendroglioma
  • Anaplastic Astrocytoma
  • Pilocytic Astrocytoma
  • Oligodendroglioma
  • Gliomatosis Cerebri
  • Pleomorphic Xanthoastrocytoma
  • Anaplastic Pleomorphic Xanthoastrocytoma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Ependymoma
  • Ependymoma, Anaplastic
  • Medulloblastoma
  • Teratoid Rhabdoid Tumor
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors
  • Anaplastic Meningioma
  • Atypical Meningioma
  • Choroid Plexus Neoplasms
  • Pineal Tumor
  • Diffuse Astrocytoma
  • Glial Tumor

Interventions

DRUG

ONC206

ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04541082 on ClinicalTrials.gov