Oral OKN-007 for Brain Tumor

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Oblato, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.

Eligibility Criteria

Adults with recurrent high-grade gliomas (WHO Grade 3 or 4) who have had no more than two prior treatments, including radiotherapy and chemotherapy. Participants must be in good physical condition (ECOG <2), not pregnant, willing to use contraception, and able to swallow oral medications. They should have adequate organ function and a life expectancy of at least three months.

Inclusion Criteria

I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.

Have provided written informed consent

My brain tumor has grown or come back, confirmed by an MRI.

+13 more

Exclusion Criteria

Serious concomitant systemic disorders, for example, abnormal electrocardiogram (ECG) indicative of cardiac disease (patients with Fridericia-corrected QT interval [QTcF] >480 msec

I am not pregnant or breastfeeding.

Patients with abnormal sodium, potassium, or creatinine levels grade ≥2

+6 more

Participant Groups

The trial is testing different doses of an oral drug called OKN-007 taken either twice or three times daily for safety and how the body processes it. It's open-label, meaning everyone knows what treatment they're getting, and involves multiple centers where patients are being studied.

4Treatment groups

Experimental Treatment

Group I: Mid-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention

Dose Escalation Cohort 3

Group II: Low-dose OKN-007, two times a day (BID)Experimental Treatment1 Intervention

Dose Escalation Cohort 1

Group III: Low-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention

Dose Escalation Cohort 2

Group IV: High-dose OKN-007, three times a day (TID)Experimental Treatment1 Intervention

Dose Escalation Cohort 4