WP1066 + Radiation for Glioblastoma

Not currently recruiting at 1 trial location
AB
CA
Overseen ByChristina Amidei
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a new drug, WP1066 (a STAT3 inhibitor), with radiation therapy can effectively treat glioblastoma, a challenging brain cancer. WP1066 targets a pathway that aids tumor growth and evasion from the immune system, while radiation therapy aims to slow tumor growth. The goal is to determine if this combination can prevent cancer progression and extend patient survival. Individuals with newly diagnosed glioblastoma, regardless of whether their tumors have been fully removed, might be eligible. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any active anti-cancer therapy and certain medications that interact with specific enzymes at least 2 weeks before starting the trial. If you are on medications that interact with CYP450 enzymes, you may need to stop them 2 weeks prior, and for some other medications, 7 days prior. Please consult with the trial team to review your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that WP1066, a drug targeting a pathway linked to tumor growth, has undergone previous studies. In earlier human trials, WP1066 caused some side effects but was generally well-tolerated. For instance, a study on patients with malignant glioma (a type of brain cancer) examined the side effects and appropriate doses of WP1066. This research provides some understanding of its safety, although the treatment remains under investigation.

Combining WP1066 with radiation therapy appears promising and aims to improve survival by halting tumor growth. While still experimental, this treatment builds on existing evidence that patients can tolerate WP1066. However, since this trial is ongoing, more information is needed to fully understand the safety of WP1066 when used with radiation therapy. Researchers will closely monitor participants for any side effects during treatment.12345

Why are researchers excited about this trial's treatments?

Most treatments for glioblastoma, like temozolomide and radiation therapy, work by attacking rapidly dividing cancer cells, but WP1066 offers a fresh approach. Researchers are excited about WP1066 because it targets a specific protein known as STAT3, which plays a key role in tumor growth and immune system evasion. By inhibiting STAT3, WP1066 not only aims to directly hinder tumor progression but also potentially boosts the body’s immune response against the cancer. This dual action could make WP1066 a powerful complement to traditional treatments, providing new hope for patients with this aggressive brain cancer.

What evidence suggests that the combination of WP1066 and radiation therapy might be an effective treatment for glioblastoma?

This trial studies WP1066 in combination with radiation therapy to treat glioblastoma, a type of brain cancer. WP1066 targets the STAT3 pathway, which aids tumor growth and immune evasion. Participants will receive WP1066 alongside radiation therapy. Early results from previous research suggest this combination can extend patient survival and enhance the body's ability to fight the tumor. In a previous study, models treated with WP1066 lived 55.5% longer. Although tumors eventually grew in all patients in some studies, this approach showed significant activity that could be helpful. This suggests that using WP1066 with radiation could be a promising treatment for glioblastoma.13678

Who Is on the Research Team?

AH

Amy Heimberger

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, histologically confirmed glioblastoma multiforme (GBM), IDH wild-type. Participants must have certain blood and organ function levels within normal ranges and be able to undergo MRI with contrast. Women of childbearing potential and men must agree to use contraception during the study.

Inclusion Criteria

I have been newly diagnosed with a specific type of brain tumor called glioblastoma.
I have measurable brain disease confirmed by an MRI within the last 4 weeks.
My doctors believe surgery could help manage my symptoms.
See 20 more

Exclusion Criteria

I have received bevacizumab before.
I am using Optune and cannot safely stop it before starting the trial therapy.
Receipt of investigational agents within =< 2 weeks prior to registration
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive WP1066 orally for 6 weeks during routine radiation therapy

6 weeks
Weekly visits for radiation therapy

Extended Treatment

Patients continue to receive WP1066 for twelve 28-day cycles

12 months
Monthly visits for WP1066 administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months
Regular follow-up visits including MRI and blood sample collection

What Are the Treatments Tested in This Trial?

Interventions

  • Radiation Therapy
  • WP1066
Trial Overview The trial examines how well WP1066, a STAT3 inhibitor, works alongside radiation therapy in treating glioblastoma. It aims to target pathways promoting tumor growth and immune evasion. The effectiveness of this combination treatment on tumor control and survival is being studied.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort II (WP1066, radiation, surgery)Experimental Treatment5 Interventions
Group II: Cohort I (WP1066, radiation)Experimental Treatment4 Interventions

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Radiation Therapy for:
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Approved in United States as Radiation Therapy for:
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Approved in Canada as Radiation Therapy for:
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Approved in Japan as Radiation Therapy for:
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Approved in China as Radiation Therapy for:
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Approved in Switzerland as Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Moleculin Biotech, Inc.

Industry Sponsor

Trials
8
Recruited
550+

Published Research Related to This Trial

In a study of 73 patients with glioblastoma multiforme, locoregional radioimmunotherapy (LR-RIT) demonstrated a safety profile with 75% of patients achieving disease stabilization and no major hematological toxicity observed.
The combination of LR-RIT with Temozolomide (TMZ) significantly improved overall survival (25 months) and progression-free survival (10 months) compared to LR-RIT alone, indicating that this combined treatment approach is both effective and safe.
Combined treatment of glioblastoma patients with locoregional pre-targeted 90Y-biotin radioimmunotherapy and temozolomide.Bartolomei, M., Mazzetta, C., Handkiewicz-Junak, D., et al.[2018]
GammaTile® Surgically Targeted Radiation Therapy (STaRT) offers a novel approach to brain tumor treatment by using a bioresorbable tile that delivers radiation while minimizing direct contact with brain tissue, which helps reduce normal brain toxicity.
This therapy has been FDA approved since 2018 for recurrent brain tumors and expanded in 2020 to include newly-diagnosed malignant tumors, with ongoing trials aimed at comparing its efficacy and safety against standard radiation treatments.
Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review.Odia, Y., Gutierrez, AN., Kotecha, R.[2023]
The combination of anti-GITR monoclonal antibody (mAb) and stereotactic radiosurgery (SRS) significantly improved survival rates in a mouse model of glioblastoma, with a cure rate of 24% compared to 0% for either treatment alone, indicating a strong immune-mediated effect.
The treatment with anti-GITR (1) and SRS led to increased infiltration of CD4+ effector T-cells and enhanced production of immune signaling molecules like IFNγ and IL-2, suggesting that this combination effectively shifts the immune response against the tumor.
Agonist anti-GITR monoclonal antibody and stereotactic radiation induce immune-mediated survival advantage in murine intracranial glioma.Patel, MA., Kim, JE., Theodros, D., et al.[2022]

Citations

A first-in-human Phase I trial of the oral p-STAT3 inhibitor ...Similar results have been seen in genetically engineered murine models of gliomas treated with WP1066 in which there was a 55.5% increase in ...
Study Details | NCT05879250 | WP1066 and Radiation ...This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult ...
Initial Results from Phase 2 Trial of STAT3 Inhibitor and ...The preclinical data were highly promising, showing that WP1066 combined with radiation therapy extended survival and triggered anti-tumor ...
A first-in-human Phase I trial of the oral p-STAT3 inhibitor ...The median overall survival (OS) rate was 25 months (95% CI: 22.5 months-NA months), with an estimated 1-year OS rate of 100%. Pharmacokinetic (PK) data ...
Clinical outcome data of WP1066 treated patients (A) PFS ...Although WP1066 demonstrated biological activity, all patients experienced radiologically confirmed progressive disease (PD) with a six-month progression-free ...
Study Details | NCT01904123 | STAT3 Inhibitor WP1066 in ...This phase I trial studies the side effects and best dose of STAT3 inhibitor WP1066 in treating patients with malignant glioma that has come back or ...
Clinical Trials Using STAT3 Inhibitor WP1066 - NCINCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying stat3 inhibitor wp1066.
First Glioblastoma Patients Treated in Phase II Trial of ...We were very encouraged by the preclinical data that demonstrated by WP1066 in combination with radiation therapy increased survival and induced ...
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