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NST-628 for Brain Cancer

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Nader Sanai
Must not be taking: Anti-cancer antibodies, Chemotherapy
Disqualifiers: Extracranial disease, Retinal pathology, CV risk, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with recurrent Grade 4 glioma who have high pERK levels in their tumor, are scheduled for brain surgery, and have already tried standard treatments. Participants must be able to swallow pills, have good organ function, and not be pregnant or breastfeeding.

Inclusion Criteria

Agrees to adhere to protocol defined Lifestyle Considerations starting at screening
Able and willing to comply with scheduled visits, treatment plans, laboratory tests, and procedures
Understands and voluntarily agrees to participate by providing written informed consent before any screening procedures
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Exclusion Criteria

I have not had recent cancer treatments or serious side effects in the last 28 days.
I have cancer outside the brain or in the lining of my brain or spinal cord.
I have a history of serious heart problems or abnormal heart rhythms.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 0

Participants receive multiple doses of NST-628 orally prior to planned surgical resection. Blood, CSF, and tumor tissue are collected intraoperatively to assess PK and PD endpoints.

Up to 4 weeks
Intraoperative collection

Phase 1

Participants receive NST-628 orally every other day in 28-day cycles until disease progression, unacceptable toxicity, or other criteria are met.

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment. Survival data collection for participants who terminate study treatment.

12 months after last participant's last visit

What Are the Treatments Tested in This Trial?

Interventions

  • NST-628

Trial Overview

The study tests a new drug called NST-628 in people with aggressive brain tumors. All participants receive the drug before surgery to see how it behaves in the body and affects the tumor. The main goals are to check safety, side effects, and early signs of effectiveness.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Recurrent Grade 4 GliomaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials
11
Recruited
440+

Barrow Neurological Institute

Collaborator

Trials
27
Recruited
7,100+

Nested Therapeutics, Inc

Industry Sponsor

Trials
1
Recruited
230+

Dignity Health

Collaborator

Trials
3
Recruited
350+

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