Nader Sanai
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.
The study includes two components, a Phase 0 design and an expansion Phase 1 design. Participants in the Phase 0 component will receive multiple doses of NST-628 orally prior to their planned surgical resection. Blood, CSF, and tumor tissue will be collected intraoperatively to assess PK and PD endpoints. Participants whose tumors express a positive PD response in gadolinium non-enhancing tissue will be eligible to enroll into the Phase 1 component. Participants in the Phase 1 component will receive NST-628 orally every other day in 28-day cycles. Participants will receive NST-628 as long as…
Inclusion Criteria: * 1\. 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. * 2\. Has sufficient archival or biopsy brain tumor tissue available to confirm eligibility, and the tissue must have an H-Score \> 150 for pERK. * 3\. 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. * 4\. Age ≥ 18 at time…
NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.
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