OKN-007 + Temozolomide for Recurrent Brain Cancer

Recruiting at12 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oblato, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called OKN-007 combined with a chemotherapy drug, temozolomide, in patients whose brain cancer has returned after standard treatments. OKN-007 may help reduce tumor growth and make the chemotherapy more effective. Temozolomide is effective in treating malignant brain tumors.

Research Team

Shinwook Kang

Principal Investigator

Oblato, Inc.

Eligibility Criteria

Adults with recurrent glioblastoma who've had standard treatment including surgery, radiation, and chemotherapy. They must have good organ function and performance status (able to carry out daily activities), no severe side effects from previous treatments, no more than two prior GBM therapies excluding bevacizumab as second line, and a confirmed diagnosis based on tissue analysis.

Inclusion Criteria

My scans show clear tumor growth, and I have at least one tumor that can be measured.

My glioblastoma was confirmed and I've had specific treatments but not bevacizumab.

I have recovered from side effects of previous treatments.

Exclusion Criteria

Inability to comply with protocol or study procedures

Serious concomitant systemic disorders

Abnormal sodium, potassium, or creatinine levels ≥ grade 2

Treatment Details

Interventions

• OKN-007 (Other)
• Temozolomide (Alkylating agents)

Trial Overview The trial is testing OKN-007 in combination with Temozolomide for safety, effectiveness, and how the body processes it. Participants must show clear signs of tumor recurrence on MRI but should not have received certain other treatments recently or have serious health issues that could interfere.

Participant Groups

Group I: All patients Experimental Treatment 2 Interventions

All patients enrolled in this study

Who Is Running the Clinical Trial?

Oblato, Inc.

Lead Sponsor

Trials

5

Recruited

100+