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MeningiomaPhase 2NCT07533942

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

A Phase 2 study testing JZP3507 in people with Meningioma, run by Jazz Pharmaceuticals at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
JZP3507
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
8 sitesUnited States
Study dates
16 Jul 2026to 16 Oct 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Has an expected survival of at least 12 weeks, as predicted by the physician.
  • Is able to submit at least 10 (preferably ≥ 15 slides, if available) unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block with sufficient material for ~15 slides from participant's tumor tissue to the sponsor.
  • Has had an MRI within 28 days before the start of study intervention, with the corticosteroid dose stable or decreasing at least 5 days prior to the scan.
  • Sex and Contraceptive/Barrier Requirements
  • Agrees to the following based on sex assigned at birth: is not of child-bearing potential or agrees to use appropriate contraception, as defined in protocol, for males and females.

Who cannot join

  • 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
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  • 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
  • Has previous exposure to JZP3507 or dordaviprone from any source.
  • Diagnostic Assessments
  • Has optic nerve sheath meningioma, extracranial meningioma, or meningioma primarily localized spinal cord.
  • Has more than 3 measurable lesions.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosures & Transparency contact

215-832-3750

ClinicalTrialDisclosure@jazzpharma.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Mass General

    Boston, Massachusetts, 02114

    Not yet recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Indiana University Health Neurosurgery Clinic

    Indianapolis, Indiana, 46202

    Recruiting

  • Yale-New Haven Hospital - Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Louisiana State University

    New Orleans, Louisiana, 70112

    Recruiting

  • NYU- Langone Health

    New York, New York, 10016

    Recruiting

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Not yet recruiting

  • Sutter Health

    San Francisco, California, 94109

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP3507 (ONC206) in Adults With Recurrent Grade 2 or 3 Meningioma

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
Being tested
JZP3507
Keywords
Grade 2 Meningioma, Grade 3 Meningioma, JZP3507, Recurrent Meningioma, ONC206, H3 K27me3 loss
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP3507Drug

    Also called ONC206

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

Study groups in NCT07533942
Study groupRoleWhat they receive
JZP3507 (ONC206)ExperimentalNot described
Receives: Drug: JZP3507

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.

Secondary outcomes (13)

  1. Duration of Response (DOR)

    DOR is the time from the first objective response (CR, PR, or MR) that is subsequently confirmed to documented progressive disease (PD) per RANO criteria or death from any cause.

    Measured: From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.

  2. Time to Response (TTR)

    TTR is the time from the first dose of the study intervention to the first objective response (CR, MR, or PR) subsequently confirmed per RANO criteria.

    Measured: From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.

  3. Disease Control Rate (DCR)

    Proportion of participants who achieved disease control in the study.

    Measured: From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.

  4. Progression-Free Survival (PFS)

    PFS is the time from the first dose of study intervention to the date of first documented PD per RANO criteria (evaluated by BICR) or death from any cause, whichever occurs first.

    Measured: From first dose to date of documented disease progression or death, up to 36 months.

  5. Overall Survival (OS)

    OS is the time from the first dose of the study intervention to death from any cause.

    Measured: From first dose until death, or up to 36 months.

  6. Incidence of Grade 3 or higher Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 36 months.

  7. Number of Adverse Events (AEs) Resulting in Study Discontinuation

    Measured: Up to 36 months.

  8. Maximum Observed Plasma Concentration (Cmax) of JZP3507

    Measured: Up to 36 months.

  9. Time of Maximum Observed Plasma Concentration (Tmax) of JZP3507

    Measured: Up to 36 months.

  10. Area Under the Concentration-Time Curve Over a Time interval (AUC(0-τ)) of JZP3507

    Measured: Up to 36 months.

  11. Terminal Elimination Half-life ( t½) of JZP3507

    Measured: Up to 36 months.

  12. Apparent Oral Clearance (CL/F)

    Measured: Up to 36 months.

  13. Apparent Volume of Distribution After Oral Dose (Vz/F)

    Measured: Up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start16 Jul 2026
  3. Primary completion25 Oct 2028 (estimated)
  4. Study completion16 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533942
Sponsor's protocol ID
JZP3507-202
Status last verified
Oct 2026
First submitted
10 Apr 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy, contact clinicaldatasharing@jazzpharma.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JZP3507 in people with Meningioma, run by Jazz Pharmaceuticals at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosures & Transparency (215-832-3750, ClinicalTrialDisclosure@jazzpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria and Evaluated by Blinded Independent Central Review (BICR) (time frame: From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07533942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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