NCT07784985
A Study of NST-628 in Recurrent Grade 4 Glioma
Not Yet Recruiting · Early Phase 1 · Nader Sanai · registry updated 2026-09-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is an open-label, single arm, non-randomized, Phase 0 and expansion Phase 1 study of NST-628 in adult patients with recurrent Grade 4 glioma with high phosphorylated extracellular signal-regulated kinase (pERK) expression who are scheduled for surgical resection. This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, and anti-tumor activity of NST-628.
Inclusion
- \. Diagnosed with Grade 4 glioma, who have progressed on or following standard of care therapy, including maximal safe resection (biopsy allowed if resection was deemed unsafe) and concurrent chemoradiation.
- \. Has sufficient archival or biopsy brain tumor tissue available to confirm eligibility, and the tissue must have an H-Score \> 150 for pERK.
- \. Is clinically indicated for tumor resection and has measurable disease (preoperatively), defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.
- \. Age ≥ 18 at time of consent.
- \. Has a performance status of ≤ 2 on the ECOG scale.
- \. Able to swallow oral medications without crushing or chewing.
Exclusion
- \. Has extracranial disease, or evidence of leptomeningeal disease.
- \. Has a history or current evidence of significant retinal pathology associated with an increased risk of RVO, including any of the following: a. History of RVO; b. Visible retinal pathology as assessed by ophthalmic examination, such as: i. Evidence of new optic disc cupping; ii. Evidence of new peripheral visual field defects; iii. Intraocular pressure \> 21 mmHg; iv. Evidence of retinal detachment.
- \. Has a history or evidence of CV risk, including any of the following: a. QT interval corrected for heart rate using the Fridericia's formula, QTcF ≥ 470 msec; b. History or evidence of current, clinically significant, uncontrolled arrhythmias (those that would require a pacemaker and are not normalized by medication: symptomatic A-fib, clinically significant 2nd or 3rd degree heart block, other clinically significant supraventricular arrhythmias, any obvious ventricular arrhythmias); c. History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to Study Day 1; d. NYHA Class II or higher congestive heart failure; e. Treatment-refractory hypertension, defined as systolic blood pressure \> 140mmHg and/or diastolic \> 90mmHg despite anti-hypertensive therapy; f. Presence of intracardiac defibrillator or pacemaker.
- \. Has a history or current evidence of pneumonitis or ILD within 6 months of Day 1.
- \. Has received more than 2 lines of prior systemic therapy.
- \. Has received chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies/antibody-drug conjugates within 28 days prior to Day 1, or ongoing treatment-related AEs Grade \> 1 per NCI-CTCAE v5.0 (excluding alopecia) at the time of starting study treatment. Individuals with chronic Grade 2 unresolved toxicities might be deemed eligible following discussion with the Sponsor-Investigator.