Multiple clinical trials are evaluating WP1066 for advanced central nervous system malignancies and intracranial metastases, including pediatric and adult brain tumors, medulloblastoma, recurrent malignant glioma, IDH-wildtype glioblastoma, and melanoma brain metastases. Led predominantly by academic research institutions such as Emory University, Northwestern University, and M.D. Anderson Cancer Center, these Phase 1 and Phase 2 studies range from completed early-phase safety evaluations to active combination trials with radiation therapy.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05879250 | RECRUITING | Glioblastoma, IDH-Wildtype; MGMT-Unmethylated Glioblastoma |
Northwestern University |
2024-05-22 | PHASE2 |
| NCT04334863 | COMPLETED | Brain Tumor; Medulloblastoma; Brain Metastases |
Emory University |
2020-05-04 | PHASE1 |
| NCT01904123 | COMPLETED | Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Recurrent Brain Neoplasm; Recurrent Glioblastoma; Recurrent Malignant Glioma |
M.D. Anderson Cancer Center |
2018-07-13 | PHASE1 |
| NCT04334863 | Completed | Brain Tumor|Medulloblastoma|Brain Metastases |
Emory University|CURE Childhood Cancer Inc.|Peach Bowl LegACy Fund |
2020-05-04 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-07-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).