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Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma

NCT05561374 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-29

No results posted yet for this 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.

Conditions

Interventions

DRUG

Low-dose OKN-007, BID

Participants will be administered low doses of oral OKN-007 two times a day daily in 28-day cycles.

DRUG

Low-dose OKN-007, TID

Participants will be administered low doses of oral OKN-007 three times a day daily in 28-day cycles.

DRUG

Mid-dose OKN-007, TID

Participants will be administered mid doses of oral OKN-007 three times a day daily in 28-day cycles.

DRUG

High-dose OKN-007, TID

Participants will be administered high doses of oral OKN-007 three times a day daily in 28-day cycles.

Sponsors & Collaborators

  • Oblato, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2025-05-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561374 on ClinicalTrials.gov