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WP1066 + Radiation for Glioblastoma
Phase 2
Recruiting
Led By Amy Heimberger
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months post-registration
Awards & highlights
Summary
This trial tests a drug/radiation combo to treat glioblastoma, a hard-to-treat brain tumor. The drug targets a specific pathway to stop growth, and radiation prevents the tumor from growing. This may extend survival.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical reactions associated with cancer therapies such as fatigue, nausea, skin irritation from radiation, possible allergic reactions to contrast agents used in MRIs, or specific issues related to the experimental drug WP1066.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months post-registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months post-registration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS) (Cohort 1)
Secondary study objectives
Duration of response (DOR)
Frequency of adverse events
Overall Response Rate (ORR)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (WP1066, radiation, surgery)Experimental Treatment5 Interventions
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.
Group II: Cohort I (WP1066, radiation)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2020
Completed Phase 2
~160
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
STAT3 Inhibitor WP1066
2018
Completed Phase 1
~10
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,961 Total Patients Enrolled
326 Trials studying Glioblastoma
23,143 Patients Enrolled for Glioblastoma
Moleculin Biotech, Inc.Industry Sponsor
6 Previous Clinical Trials
179 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,250 Total Patients Enrolled
12 Trials studying Glioblastoma
429 Patients Enrolled for Glioblastoma
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