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Also known as STAT3 Inhibitor WP1066
WP1066 · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Cohort I (WP1066, radiation) | EXPERIMENTAL | 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. |
| Cohort II (WP1066, radiation, surgery) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * 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 ...
WP1066 is being studied for the treatment of glioblastoma, specifically IDH-wildtype glioblastoma that is MGMT-unmethylated. It is an investigational small molecule in Phase 2 development and is not approved for any indication. The ongoing trial evaluates WP1066 in combination with radiation therapy in patients with newly diagnosed disease.
WP1066 targets phosphorylated STAT3, or p-STAT3, a transcription factor. By inhibiting p-STAT3, the drug is designed to interfere with signaling pathways that support tumor growth and survival. This mechanism is being explored in oncology, particularly in glioblastoma, where STAT3 activation is thought to contribute to treatment resistance.
WP1066 is being developed by Moleculin Biotech, Inc., a clinical-stage pharmaceutical company that trades under the ticker symbol MBRX. The company is advancing the drug as a potential treatment for glioblastoma and other cancers, with the current focus on a Phase 2 trial in newly diagnosed IDH-wildtype glioblastoma.
WP1066 is in Phase 2 clinical development. The only listed trial is a Phase 2 study that is currently recruiting participants. The drug is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
WP1066 is being evaluated in one clinical trial, NCT05879250, titled "WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma." This Phase 2 trial is recruiting an estimated 39 patients in the United States. It is a controlled study that includes patients with IDH-wildtype, MGMT-unmethylated glioblastoma.
Yes, WP1066 is also known as STAT3 Inhibitor WP1066. Both names refer to the same investigational small molecule developed by Moleculin Biotech. The alternative name reflects its mechanism of targeting p-STAT3.