Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing PLX038 for Glioma

Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years.

Official registry: https://clinicaltrials.gov/study/NCT06161519 · National Cancer Institute (NCI) · enrollment listed as 146

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are PLX038. The registry lists allocation as randomized. Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States.

They plan to enroll about 146 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase I/II Trial of PLX038 in Primary Central Nervous System Tumors With and Without MYC or MYCN Amplifications

Interventions: PLX038

Primary outcome (registry wording): Phase I: To confirm the RP2D of PLX038 in participants with progressive or recurrent primary CNS tumors

Who it is for (from inclusion criteria)

  • Ages 18 Years to 120 Years
  • Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:
  • Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features
  • Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation
  • Recurrent or progressive MYCN amplified ependymoma, OR
  • Recurrent or progressive medulloblastoma with MYC or MYCN amplifications
  • Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications
  • Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications

Public study contact (from the registry)

NCI NOB Referral Group

(866) 251-9686

ncinobreferrals@mail.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06161519 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06161519?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06161519?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary