A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma

NCT07533942 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: JZP3507-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of JZP3507. The antitumor activity and safety of JZP3507 will be evaluated.

Conditions

Meningioma

Keywords

Grade 2 Meningioma; Grade 3 Meningioma; JZP3507; Recurrent Meningioma; ONC206; H3 K27me3 loss

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria and Evaluated by Blinded Independent Central Review (BICR)

  ORR is the best response of confirmed complete response (CR), partial response (PR), or minor response (MR) during the study, as per RANO criteria

  From first dose until death, withdrawal of consent, or lost to follow-up, up to 40 months.

Secondary Outcomes (13)

• Duration of Response (DOR)

  From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.

• Time to Response (TTR)

  From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.

• Disease Control Rate (DCR)

  From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.

• Progression-Free Survival (PFS)

  From first dose to date of documented disease progression or death, up to 64 months.

• Overall Survival (OS)

  From first dose until death, or up to 64 months.

Study Arms (1)

JZP3507 (ONC206)

EXPERIMENTAL

Drug: JZP3507

Interventions

JZP3507 DRUG

Participants will receive oral JZP3507 monotherapy twice daily, on 3 consecutive days per week in 28-day cycles.

Also known as: ONC206

JZP3507 (ONC206)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Is ≥ 18 years of age at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Has histologically confirmed Grade 2 or 3 meningioma.
• Has failed, is not a candidate for, or has declined standard of care treatment for meningioma. Note: There is no limit on the number of prior systemic therapies.
• Has measurable disease, as assessed by the investigator. Measurable disease is defined as at least one lesion measuring ≥ 10 mm on perpendicular dimensions by contrast-enhanced MRI performed within 28 days prior to study enrollment.
• Has progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, as assessed by the investigator using axial, contrast-enhanced T1-weighted magnetic resonance imaging (MRI). PD is defined as an increase in size of the measurable primary lesion on imaging by at least 15% in sum of product of target lesions since last treatment or between scans separated by no more than 6 months. The presence of a new lesion would also qualify as PD.
• Is able to submit historic disease-related imaging from at least 9 months prior to study entry to central imaging vendor (preferably all available disease-related imaging from initial diagnosis onwards).
• Is able to swallow oral tablets.
• Has a Karnofsky Performance Status (KPS) of at least 70.
• Has laboratory test results meeting the following parameters within 14 days before the start of study intervention:
• Absolute neutrophil count ≥ 1.0 × 109/L and platelets ≥ 75 × 109/L.
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (participants with Gilbert's syndrome may be included with total bilirubin \> 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN).
• Aspartate (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. Note: For participants with documented baseline liver metastasis, the following limits will apply: ≤ 5 × ULN for transaminase.
• Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft Gault equation (or estimated glomerular filtration rate \[eGFR\] \> 60 mL/min/1.73 m2) or serum creatinine ≤ 1.5 × ULN.

You may not qualify if:

• Medical Conditions
• Has known hypersensitivity to JZP3507, dordaviprone, or any excipient used in the JZP3507 study intervention formulation.
• Has active cardiac disease/condition as defined in the protocol.
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Exceptions include participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has an active infection that requires systemic therapy.
• Prior/Concomitant Therapy
• Has received any of the following interventions within the specified time periods before the first dose of study intervention or plans to receive any of the following interventions during study participation:
• Prior anticancer therapy or investigational agents within 28 days or 5 half-lives, whichever is shorter.
• Antibody-based anticancer therapy within 42 days.
• Radiotherapy within 24 weeks (\~6 months).
• Strong CYP3A4 inhibitors within 14 days.
• Strong CYP3A4 inducers within 14 days.
• Major surgery, open biopsy, or significant traumatic injury within 30 days.
• Has uncontrolled intercurrent illness or any other medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with participant safety or the ability to comply with study requirements.
• Prior/Concurrent Clinical Study Experience

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Chimerix, Inc.: collaborator

Study Sites (5)

Sutter Health

San Francisco, California, 94109, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Mass General

Boston, Massachusetts, 02114, United States

Location

NYU- Langone Health

New York, New York, 10016, United States

Location

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Meningioma

Interventions

ONC206

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Central Study Contacts

Clinical Trial Disclosures & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@jazzpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 25, 2028
• Study Completion (Estimated): October 16, 2031
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)