Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05879250

WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Led by Northwestern University · Updated on 2025-12-30

39

Participants Needed

2

Research Sites

240 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

M

Moleculin Biotech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult to treat effectively because the cells within the tumor vary widely and are controlled by factors within and around the tumor, requiring multiple approaches to treat the tumor. The study drug WP1066 targets a specific pathway, known as STAT3, which is responsible for promoting tumor growth and causing the body's immune system to avoid attacking the tumor. Radiation therapy prevents glioblastoma from growing. Giving WP1066 with radiation therapy may prevent glioblastoma from growing and prolong survival.

CONDITIONS

Official Title

WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed, histologically confirmed WHO glioblastoma multiforme (GBM), IDH wild-type
  • Documentation of MGMT unmethylated status from a certified laboratory
  • Cohort 1: prior gross total resection (GTR) of tumor
  • Cohort 2: no prior gross total resection (GTR)
  • Cohort 2: measurable brain tumor per recent MRI within 4 weeks before treatment
  • Cohort 2: suitable for non-emergent palliative surgical resection as assessed by tumor board
  • Able to start trial therapy within 8 weeks of initial brain surgery
  • Age 18 years or older
  • Karnofsky performance score of 60% or higher
  • Adequate blood counts within 30 days before registration without recent growth factor or blood product support
  • Liver function tests within defined limits within 30 days before registration
  • Kidney function within normal limits or creatinine clearance ≥ 60 mL/min/1.73 m² within 30 days before registration
  • Normal or therapeutic coagulation tests within 30 days before registration
  • Willing and able to tolerate brain MRI with contrast, without severe allergy to contrast agents
  • Agree to use effective contraception during treatment and for specified periods after last dose
  • Ability to understand and sign informed consent
  • Men and women of all races and ethnic groups may participate
Not Eligible

You will not qualify if you...

  • Use of investigational agents within 2 weeks before registration
  • Prior gene therapy or bevacizumab treatment at any time
  • Prior Gliadel treatment at any time
  • Inability to safely discontinue Optune device before trial therapy
  • Inability to discontinue other active anti-cancer therapy before trial therapy
  • History of allergic reactions to WP1066 or its components
  • HIV-positive patients on combination antiretroviral therapy
  • Use of drugs with significant CYP450 interactions within 2 weeks before treatment
  • Use of certain CYP enzyme substrate or inhibitor drugs within 7 days before treatment
  • Need for escalating corticosteroid doses; stable or decreasing doses allowed
  • History of symptomatic brain hemorrhage; small asymptomatic hemorrhage may be allowed with approval
  • Uncontrolled seizures or need for increased anti-epileptic drugs
  • Brain lesions larger than 50 mm, or causing midline shift over 5 mm, or hydrocephalus
  • Diffuse leptomeningeal disease
  • Corrected QT interval ≥ 450 ms
  • Increased risk for radiation therapy toxicities due to certain diseases
  • Positive pregnancy test or planning pregnancy for females of childbearing potential
  • Breastfeeding unwilling or unable to stop during treatment
  • Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, psychiatric illness limiting compliance, or other conditions compromising safety or study endpoints

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Northwestern Medicine: Warrenville

Warrenville, Illinois, United States, 60555

Active, Not Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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