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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT07784985
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Glioma, Recurrent High Grade
  • Grade 4 Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Recurrent Grade 4 Glioma
    Participants with high pERK expression in pretreatment biopsy/archival tumor tissue: tumors with an H Score \> 150.

Primary Outcome Measure

Phase 0: Percent Change of pERK Expression in Tumor Tissue [ Time Frame: Intraoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Phase 0 Navigator
[email protected]
602-406-8605
Kelly Braun, MD (SUB_INVESTIGATOR)
Charuta Furey, MD (SUB_INVESTIGATOR)
Sirin Gandhi, MD (SUB_INVESTIGATOR)
Yoshie Umemura, MD (SUB_INVESTIGATOR)
Nader Sanai, MD (PRINCIPAL_INVESTIGATOR)
Karl Golnik, MD (SUB_INVESTIGATOR)

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St. Joseph's Hospital and Medical Center· Phoenix, AZ