Not Yet RecruitingPhase 2

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

United States30 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Is ≥ 18 years of age at the time of signing the informed consent.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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).

What they're measuring

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

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

Trial details

NCT IDNCT07533942

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-25

Contact for this trial

Clinical Trial Disclosures & Transparency

215-832-3750 ClinicalTrialDisclosure@jazzpharma.com

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