Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05561374 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
A Phase 1 study of Glioblastoma Multiforme and High Grade Glioma, sponsored by Oblato.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 4
- Study locations
NCT05561374: Active Phase 1 study of Glioblastoma Multiforme and High Grade Glioma, sponsored by Oblato.
NCT05561374 is a Phase 1 study of Glioblastoma Multiforme and High Grade Glioma that is active but no longer recruiting, run by Oblato. The registered enrollment target is 16 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561374, a Phase 1 study of Glioblastoma Multiforme and High Grade Glioma, is active but no longer recruiting, sponsored by Oblato.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Safety and tolerability will be evaluated from adverse events as reported according to CTCAE version 5.0.
Conditions Studied
Interventions
- DRUG Low-dose OKN-007, BID
- DRUG Low-dose OKN-007, TID
- DRUG Mid-dose OKN-007, TID
- DRUG High-dose OKN-007, TID
Study Locations (4)
California
- Providence Saint John's Cancer Institute - Santa Monica
Kentucky
- Norton Healthcare - Louisville
North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Oklahoma
- The University of Oklahoma Health Sciences Center, Stephenson Cancer Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05561374 still lists
NCT05561374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 4 interventions - of which Low-dose OKN-007, BID is the first listed.
NCT05561374 reports a single indexed study location in California, Kentucky, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05561374 about?
NCT05561374 is a clinical study titled "Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma". 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.
What is the current status of trial NCT05561374?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-04-17. Estimated completion is 2025-06-30.
What conditions does trial NCT05561374 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, High Grade Glioma, Astrocytoma, Oligodendroglioma.
What interventions are being tested in trial NCT05561374?
The interventions under investigation include: Low-dose OKN-007, BID (DRUG), Low-dose OKN-007, TID (DRUG), Mid-dose OKN-007, TID (DRUG), High-dose OKN-007, TID (DRUG).
Who is sponsoring clinical trial NCT05561374?
This trial is sponsored by Oblato, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561374 being conducted?
This trial has 4 study locations across California, Kentucky, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma Multiforme
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05561374's enrollment target sits among peer trials
16 73rd of 88 higher than 14 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
RECRUITING · Phase 1
-
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
RECRUITING · Phase 1
-
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
RECRUITING · Phase 1
-
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
RECRUITING · Phase 1
-
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
RECRUITING · Phase 1
-
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI