WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05879250
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Glioblastoma, IDH-Wildtype
  • MGMT-Unmethylated Glioblastoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Radiation Therapy — RADIATION
    Undergo routine radiation therapy
  • STAT3 Inhibitor WP1066 — DRUG
    Given PO
  • Surgical Procedure — PROCEDURE
    Undergo removal or biopsy of tumor

Study Details

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.

Key Dates

Start date
May 22, 2024
Status verified
Dec 2025
Primary completion
Dec 27, 2027
Completion
Dec 27, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (WP1066, radiation)
    Patients whose tumor was completely removed at the time of initial surgery receive WP1066 PO for 6 weeks during routine radiation therapy, and then for twelve 28-day cycles on study. Patients also undergo MRI and collection of blood samples throughout the trial.
  • Experimental: Cohort II (WP1066, radiation, surgery)
    Patients whose tumor was not fully removed at the time of initial surgery receive WP1066 PO for 6 weeks during routine radiation therapy on study. Patients may then undergo possible surgery or open biopsy if eligible, followed by twelve 28-day cycles of WP1066 PO on study. Patients also undergo MRI and collection of blood samples throughout the trial.

Primary Outcome Measure

Progression-Free Survival (PFS) (Cohort 1) [ Time Frame: From subject registration to the earlier of the day of first documented disease progression or death from any cause, assessed up to 36 months post-registration ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Amy Heimberger
[email protected]
312-503-3805
Amy Heimberger (PRINCIPAL_INVESTIGATOR)
Northwestern Medicine: WarrenvilleWarrenvilleIllinois60555-

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By research site
Northwestern University· Chicago, ILNorthwestern Medicine: Warrenville· Warrenville, IL

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