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STAT3 Inhibitor 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 ...
STAT3 Inhibitor WP1066 is an investigational small molecule being studied for the treatment of newly diagnosed glioblastoma, specifically IDH-wildtype and MGMT-unmethylated glioblastoma. It is currently in Phase 2 clinical development and has not been approved by the FDA.
STAT3 Inhibitor WP1066 targets STAT3, a transcription factor involved in cancer cell growth and survival. By inhibiting STAT3, the drug aims to block tumor-promoting signaling pathways in glioblastoma.
STAT3 Inhibitor WP1066 is being developed by Moleculin Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MBRX.
STAT3 Inhibitor WP1066 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting patients.
STAT3 Inhibitor WP1066 is being evaluated in a single Phase 2 clinical trial, NCT05879250, titled 'WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma.' The trial is recruiting 39 participants in the United States and is not randomized or double-blind.