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A Phase 0/1 Study of NST-628 in Recurrent Grade 4 Glioma

NCT07784985 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Glioma, Recurrent High Grade
  • Grade 4 Malignant Glioma

Interventions

DRUG

NST-628

NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • Nested Therapeutics, Inc

    collaborator INDUSTRY

  • Dignity Health

    collaborator OTHER

  • Nader Sanai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784985 on ClinicalTrials.gov