Oral OKN-007 for Brain Tumor

Not currently recruiting at 3 trial locations

Overseen By Shinwook Kang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oblato, Inc.

Must not be taking: Bevacizumab, Chemotherapeutics

Disqualifiers: Prior malignancy, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called OKN-007 for individuals with recurrent high-grade gliomas. The main goal is to assess the treatment's safety and the body's tolerance at different doses. The trial includes various groups to determine the optimal dose. Individuals with recurrent high-grade gliomas who have undergone no more than two prior treatments may qualify. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have received certain treatments like chemotherapeutic agents within 28 days before starting the study.

Is there any evidence suggesting that OKN-007 is likely to be safe for humans?

Research has shown that OKN-007 has been studied for its safety in patients with serious brain tumors. In a previous study, researchers tested OKN-007 with another drug called temozolomide, including patients with brain tumors like glioblastoma. The results indicated that patients generally tolerated OKN-007 well.

Some side effects occurred, but they were mostly manageable. Since this trial is in an early stage, the main goal is to assess the treatment's safety and patient tolerance. Researchers continue to gather information to understand all possible side effects. The fact that multiple studies are testing OKN-007 suggests it is considered safe enough for further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain tumors, such as surgery, radiation, and chemotherapy, OKN-007 is an oral medication designed to be taken either two or three times a day. It targets specific molecular pathways involved in tumor growth, potentially offering a more precise approach to combating brain tumors. Researchers are excited about OKN-007 because it represents a non-invasive treatment option that could improve outcomes with fewer side effects compared to traditional therapies. Additionally, the dose escalation approach aims to find the optimal dosage for effectiveness, which could lead to personalized treatment strategies for patients.

What evidence suggests that OKN-007 might be an effective treatment for brain tumors?

Research has shown that OKN-007 may help treat brain tumors. In animal studies, OKN-007 reduced tumor size and extended lifespan. Another study found it slowed tumor growth and reduced tissue damage. When combined with temozolomide, a common cancer drug, OKN-007 improved outcomes in treating glioblastoma, a type of brain cancer. These findings suggest that OKN-007 could effectively treat aggressive brain tumors. Participants in this trial will receive varying dosages of OKN-007 to evaluate its effectiveness and safety. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral OKN-007 daily in 28-day cycles with dose escalation across cohorts

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OKN-007

Trial Overview 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.

How Is the Trial Designed?

Group I: Mid-dose OKN-007, three times a day (TID) Experimental Treatment 1 Intervention

Dose Escalation Cohort 3

Group II: Low-dose OKN-007, two times a day (BID) Experimental Treatment 1 Intervention

Dose Escalation Cohort 1

Group III: Low-dose OKN-007, three times a day (TID) Experimental Treatment 1 Intervention

Dose Escalation Cohort 2

Group IV: High-dose OKN-007, three times a day (TID) Experimental Treatment 1 Intervention

Dose Escalation Cohort 4

Who Is Running the Clinical Trial?

Oblato, Inc.

Lead Sponsor

Trials

5

Recruited

100+

Published Research Related to This Trial

A study analyzing 202 adverse events (AEs) reported by patients on health forums found that musculoskeletal disorders were reported more frequently than in the French pharmacovigilance database (FPVD), suggesting patients may experience and discuss these issues more openly online.

In contrast, skin disorders were reported less frequently on patient websites compared to the FPVD, and overall, the AEs shared by patients were less serious than those recorded in the FPVD, indicating a potential difference in the severity of AEs perceived by patients versus those documented in formal reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undesirable effects related to oral antineoplastic drugs: comparison between patients' internet narratives and a national pharmacovigilance database. Pages, A., Bondon-Guitton, E., Montastruc, JL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8773900/

OKN-007 Alters Protein Expression Profiles in High-Grade ... In preclinical studies, our group found that OKN-007 was very effective in significantly reducing tumor volumes and elevating animal survival ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04388475

Open-label Study Investigating of OKN-007 Combined With ... This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022356524000235

Oklahoma nitrone-007 is an effective anticancer ... A marked reduction in tumor burden was observed in mice receiving OKN-007 compared with UT mice when compared at day 21 after cell implantation (average ...

4. withpower.com withpower.com/trial/phase-1-glioblastoma-8-2018-fe4e0

OKN-007 + Temozolomide for Glioblastoma Temozolomide, when used with radiotherapy, has been shown to improve survival in glioblastoma patients, with a two-year survival rate of 26.5% compared to 10.4% ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6190608/

OKN-007 Decreases Tumor Necrosis and Tumor Cell ... Conclusion: OKN-007 reduces both necrosis and tumor cell proliferation, as well as seems to mediate multiple effects in different tumor regions (tumor necrotic ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-03791

OKN-007 and Temozolomide in Treating Patients with ... This early phase I trial studies the side effects of OKN-007 and temozolomide in treating patients with grade III-IV glioblastoma multiforme undergoing ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04388475/

Clinical Trial: NCT04388475 This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide( ...