Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing repeated oral doses of NEO212, an experimental treatment, on its own in IDH-mutant astrocytoma and IDH-wildtype glioblastoma, and alongside selected standard treatments for solid cancers with uncontrolled brain metastases. They will assess how the drug is absorbed and handled by the body, as well as its safety and possible anti-cancer activity.
The idea is that an oral treatment that reaches the brain could help control tumours there, either alone or combined with existing treatments. This trial mainly measures safety and tolerability first, with drug levels and signs of tumour control assessed later; it has no comparison group to show whether patients live longer or remain progression-free than with standard care.
Worth knowing: It is an open-label, non-randomised early-phase trial, so it is primarily testing safety and drug behaviour rather than proving benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06047379 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 134 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Neonc Technologies, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug NEO212 Oral Capsule
- Drug Ipilimumab
- Drug Pembrolizumab
- Drug Nivolumab
- Drug Regorafenib
- Drug Carboplatin
- Drug Paclitaxel
- Drug FOLFIRI Protocol
- Drug Bevacizumab
What it is measuring
Phase 1: safety and tolerability of increasing dose levels of orally administered NEO212 alone in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or patients with select solid tumors with uncontrolled metastases to the brain
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.
The study will have three phases, Phase 1, Phase 2a and Phase 2b.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- dMMR / MSI-H
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Patient must be ≥ 18yrs of age.
- Patient must have the ability to understand, and the willingness to sign, a written informed consent form.
- Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
- Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.
- If progression of disease occurs within 90 days or conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection.
- Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.
- Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient must have an expected survival or at least three months.
- Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.
- Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.
- Patients must be able to comply with all study assessments.
- If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.
- Patient must have adequate orga…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 8 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06047379, registered by Neonc Technologies, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.