ONC201 in Adults With Recurrent H3 K27M-mutant Glioma

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Chimerix

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests ONC201, a pill that targets proteins, in adults with recurring aggressive brain cancer. It works by blocking a protein that helps cancer cells grow. ONC201 has shown anti-cancer activity in various types of cancer.

Research Team

Eligibility Criteria

Inclusion Criteria

Patients must have had previous therapy with at least radiotherapy.

Nuclear medicine imaging, MR spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than pseudoprogression or radiation necrosis obtained within 28 days of registration.

From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.

See 29 more

Exclusion Criteria

Current or planned participation in a study of an investigational agent or using an investigational device.

Presence of diffuse leptomeningeal disease or evidence of CSF dissemination.

Active infection requiring systemic therapy.

See 15 more

Treatment Details

Interventions

ONC201 (Imipridone DRD2 Antagonist)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 Intervention

ONC201 in relapsed H3 K27M glioma, excluding: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/Kg * Tumors with known 1p/19q co-deletion.

Group II: Arm AExperimental Treatment1 Intervention

ONC201 in relapsed H3 K27M glioma