WP1066 and Radiation Therapy for Newly Diagnosed Glioblastoma
This study is testing a new combination treatment for newly diagnosed glioblastoma, a type of brain cancer. It combines a drug called WP1066 with standard radiation therapy. WP1066 works by targeting a specific pathway (STAT3) that helps tumors grow and hide from the body's immune system. Researchers want to see if this combination can help prevent the cancer from growing and improve how long people live. You might be able to join if you have newly diagnosed glioblastoma that is IDH wild-type and MGMT unmethylated. The study will measure how long patients live without their cancer getting worse (progression-free survival) and look at changes in the tumor environment.
- Study design
- This study plans to enroll 39 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- You would undergo blood collection, MRI scans, routine radiation therapy, take WP1066 by mouth, and have a surgical procedure to remove or biopsy the tumor.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be assessed for up to 36 months after you register for the study.
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NCT05879250
WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~39 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMagnetic Resonance ImagingRadiation TherapySTAT3 Inhibitor WP1066Surgical Procedure
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) (Cohort 1)
Measured over 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
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesIllinois2
Study leadership
- Amy Heimberger · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type
External pathology reports are permitted for confirmation of histological diagnosis
Documentation of isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H immunohistochemistry, except for patients =\< age 54 for whom IDH sequencing will be required to detect noncanonical IDH mutations
Documentation of O6-methylguanine-DNA methyltransferase (MGMT) unmethylated status per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory
Cohort 1 only: Patients with prior gross total resection (GTR)
Cohort 2 only: Patients without prior gross total resection (GTR)
Cohort 2 only: Measurable disease in the brain (per RANO criteria) on brain magnetic resonance imaging (MRI) scan conducted within =\< 4 weeks prior to initiating trial therapy
Cohort 2 only: Patients who would benefit from non-emergent, palliative surgical resection, in the opinion of the local site's tumor board
Able to initiate trial therapy within 8 weeks of the initial brain surgical procedure (biopsy or resection) that lead to the patient's initial diagnosis of GBM
Age \>=18 years
Karnofsky performance scale score \>= 60%
White blood cell (WBC) count \>= 3.0 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
Platelet count \>= 75 x 10\^9/L (within =\< 30 days prior to registration) (without growth factor support and/or receipt of blood products within =\< 14 days prior to testing)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 x ULN (within =\< 30 days prior to registration)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x ULN (within =\< 30 days prior to registration)
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x ULN (within =\< 30 days prior to registration)
Creatinine or creatinine clearance within normal institutional limits. A creatinine level above the institutional normal limit is acceptable, provided creatinine clearance (CrCl) is \>= 60 mL/min/1.73 m\^2 (within =\< 30 days prior to registration). Creatinine clearance should be calculated using the Cockcroft-Gault formula
International normalized ratio (INR) =\< 1.5 x ULN or for subjects receiving anticoagulant therapy, INR must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator (within =\< 30 days prior to registration)
Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN or for subjects receiving anticoagulant therapy, aPTT must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator (within =\< 30 days prior to registration)
Willing and able to tolerate brain MRI with contrast. Patients with any known severe allergy to contrast agent(s) should not participate in the study. Patients with mild allergies to contrast agents (e.g., rash only) may participate in the study per treating investigator discretion; it is recommended that these patients be pretreated with acetaminophen and diphenhydramine \[or other institutional standard combination of agent(s) for allergy prep\] prior to injection of the contrast agent
Willing and able to follow the below contraception requirements:
Female subjects of childbearing potential (defined below) must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with hormonal contraception) starting from the time of informed consent, throughout the duration of treatment with WP1066, and for 2 months after the last dose of WP1066. They also must agree to not donate/freeze eggs during the same timeframe. A female of reproductive potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets both of the following two criteria:
Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
Male subjects must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with partner's use of hormonal contraception) starting from the time of informed consent, throughout the duration of treatment with WP1066, and for 4 months after the last dose of WP1066. They also must agree to not donate sperm during the same timeframe Note: The effects of WP1066 on the developing human fetus are unknown. WP1066 could potentially be teratogenic or have abortifacient effects. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Subject (or subject's legally authorized representative if subject has impaired decision-making capacity) must have the ability to understand and the willingness to sign a written informed consent document
Both men and women of all races and ethnic groups may participate in this trial
Exclusion
Receipt of investigational agents within =\< 2 weeks prior to registration
Prior receipt of gene therapy, at any time
Prior receipt of bevacizumab, at any time
Prior receipt of Gliadel, at any time
Patients who are on active therapy with Optune and who are unable to safely discontinue Optune prior to initiating trial therapy Note: Patients who can safely discontinue Optune prior to initiating trial therapy may participate
Patients who are on active therapeutic anti-cancer therapy and who are unable to discontinue the anti-cancer therapy prior to initiating trial therapy Note: Patients who discontinue anti-cancer therapy prior to initiating trial therapy may participate. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial may participate
History of allergic reactions attributed to compounds of similar chemical or biologic composition to WP1066 or its excipients
Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy Note: These patients are ineligible because of the potential for pharmacokinetic interactions with WP1066. (HIV testing is not required, unless mandated by a local health authority.)
Patients who have received drugs that significantly interact with CYP450 enzyme(s) within =\< 2 weeks prior to planned first study treatment day Note: Patients who are able to safely discontinue the aforementioned agents \> 2 weeks prior to initiating treatment with WP1066 may participate. The enzymatic metabolism profile of WP1066 is unknown. Drugs that have a minor interaction with CYP450 are allowed, and drugs with a moderate interaction are allowed at the principal investigators (PI's) discretion. Zofran (ondansetron) is allowed
Patients who have received any of the following agents within 7 days of planned first study treatment day:
Agents that are predominantly CYP2D6, 2C9, or 2C19 substrates
Agents that are strong inhibitors or inducers of CYP2D6, 2C9, or 2C19
Agents that are sensitive substrates of CYP3A4 with narrow therapeutic range Note: Patients who are able to safely discontinue the aforementioned agents \> 7 days prior to initiating treatment with WP1066 may participate. The enzymatic metabolism profile of WP1066 is unknown. Drugs that are minor CYP2D6, 2C9 or 2C19 substrates; minor inhibitors or inducers of CYP2D6, 2C9, or 2C19; or minor substrates of CYP3A4 are allowed. Moderate drugs will be allowed per PI's discretion. Zofran (ondansetron) is allowed
Patients on corticosteroids who require escalation of the corticosteroid dose Note: Patients receiving a stable or decreasing dose for at least one week may participate. Zofran (ondansetron) is allowed
History of brain hemorrhage, unless the following exception is met:
Exception: Small, asymptomatic brain hemorrhage may be permitted, provided written documentation of PI approval has been obtained Note: The potential for further hemorrhaging with the use of WP1066 is unknown. It will be at the PIs discretion to enroll a patient who has a small, asymptomatic brain hemorrhage, but patients who have had symptomatic hemorrhages will be excluded
Uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drug
Lesion(s) larger than 50 mm in maximal diameter on MRI, or with midline shift exceeding 5 mm, or with hydrocephalus
Diffuse leptomeningeal disease Note: Because one of the objectives is PFS based on radiographic volumetric analysis of the tumor, the presence of diffuse leptomeningeal disease is excluded. This is secondary to the inadequacy of measuring the extent of the tumor burden within this setting and the very poor prognosis of these patients
Corrected QT (QTc) B interval \>= 450 ms These patients are excluded because the cardiac toxicities of WP1066 are unknown. Concomitant use of agents that prolong the QT interval should be avoided whenever feasible, or used with caution. Zofran (ondansetron) is allowed
Subjects who are at increased risk for radiation therapy (RT)-associated toxicities, such as those with known active collagen vascular disease (e.g., scleroderma, Sjogren's disease, etc.) or other inherited RT-hypersensitivity syndromes (e.g., Gorlin syndrome, Fanconi anemia, ataxia-telangiectasia, etc.)
For female patients of childbearing potential only:
Breastfeeding patients who are unwilling/unable to discontinue breastfeeding while receiving WP1066 Note: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WP1066, breastfeeding should be discontinued if the mother is treated with WP1066. Patients who discontinue breastfeeding prior to initiating treatment with WP1066 may participate
Uncontrolled intercurrent illness or condition including, but not limited to any of the following:
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness/social situation that would limit compliance with study requirements
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the subject's safety or study endpoints
What this trial measures
- Progression-Free Survival (PFS) (Cohort 1)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
For PFS analysis, disease progression is defined as progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria Will be summarized using the Kaplan-Meier method.
- Tumor microenvironment activation and cluster interactions (Cohort 2)Up to 36 months post-registration