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NCT Number: NCT04388475

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.

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Key information

Conditions

Recurrent Malignant Glioma Brain Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed Glioblastoma based on histopathology or molecular profile analysis (WHO Grade IV), following primary treatment with TMZ and radiotherapy (minimum of 50 Gy) and at least two cycles of maintenance TMZ (5 days of a 28 day cycle) as first-line or second-line treatment with another treatment regimen, excluding bevacizumab.
  • Patients must have medical records available documenting O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status analysis or must have tumor tissue samples available from prior GBM surgery or open biopsy for MGMT status determination.
  • For patients with unresected recurrent tumor, unequivocal radiographic evidence of tumor progression by MRI. These patients must have at least one measurable lesion.
  • Patients with recent resection of recurrent viable tumor are eligible following post-operative MRI perfusion scan with or without measurable lesions.
  • No more than two prior lines of therapy for glioblastoma. Any second-line therapy is acceptable, excluding bevacizumab as second line.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Full recovery (≤ grade 1) from the toxic effects.
  • Adequate renal, liver and bone marrow function:
  • Hemoglobin >9.0 g/dL
  • Leukocytes >3,000/mcL
  • Absolute neutrophil count >1,500/mcL
  • Platelets >100,000/mcL
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • AST (SGOT) / ALT (SGPT) ≤2.5 × ULN
  • Creatinine clearance ≥ 60 mL/min
  • Patients must be ≥18 years of age

Exclusion criteria

  • Early discontinuation of TMZ in prior line due to treatment related Adverse events (AEs).
  • Second primary malignancy expected to require treatment within a 6 month period (except adequately treated basal cell carcinoma of the skin).
  • Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have received chemotherapeutic agents (including temozolomide) within 28 days or within 5 half-lives for non-cytotoxic agents (whichever is shorter) of study entry
  • Serious concomitant systemic disorders
  • Patients with abnormal sodium, potassium, or creatinine levels ≥ grade 2.
  • Patients with prothrombin time/partial thromboplastin time (PT/PTT) or International normalized ratio (INR) above the ULN.
  • Inability to comply with protocol or study procedures.
  • Patients who have received bevacizumab for recurrent glioblastoma or are planning to initiate treatment with bevacizumab for tumor necrosis. (Past treatment with bevacizumab for tumor necrosis is acceptable).
  • Patients receiving or planning to initiate treatment with the tumor treating fields device (Optune®) (Optune® prior to enrollment is permitted).

Treatment and study plan

OKN-007

Drug

Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.

Other names: NXY-059, HPN-07

Temozolomide (TMZ)

Drug

Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.

Other names: Temodar

Primary outcomes

  1. Incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide

    Time frame: Through study completion up to 24 months

    Evaluate incidents of Adverse Events during the subjects are taking OKN-007 with Temozolomide. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

  2. Overall Survival (OS) rate

    Time frame: 6 months

    Proportion of subjects who are alive after six months of starting treatment. OS is defined as the time from first treatment dose until date of death due to any cause.

Secondary outcomes

  1. Overall Response Rate (ORR%)

    Time frame: 24 months

    The proportion of patients with a complete response or partial response to treatment.

  2. Progression Free Survival (PFS) rate

    Time frame: 6 months

    Proportion of subjects who are alive and progression free after six months of starting treatment. PFS is defined as the time from first treatment dose until objective tumor progression on the RANO criteria or death.

  3. Cmax of OKN-007 in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  4. AUC of OKN-007 in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  5. Tmax of OKN-007 in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 10 time points during 24 hours after OKN-007 administration.

  6. Cmax of Temozolomide in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

  7. AUC of Temozolomide in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

  8. Tmax of Temozolomide in blood plasma

    Time frame: Day 1 and Day 5 in Cycle 1 and 2 (28 Day Cycle)

    The sample will be collected at 8 time points during 24 hours after Temozolomide administration.

Sponsors and collaborators

Lead sponsor

Oblato, Inc.

Industry

Registry information

Official study title

A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
May 14, 2020
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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