Several clinical trials are currently evaluating interventions across Early Phase 1 to Phase 2 stages for indications including solid malignancies—such as metastatic breast, ovarian, lung, and prostate cancers—non-alcoholic steatohepatitis, and dry age-related macular degeneration. Sponsored by leading academic institutions and pharmaceutical companies, these studies range in status from active recruitment to not yet recruiting. Notable focus areas include PET/CT imaging responses in oncology, targeted therapeutics, and treatments for degenerative disorders.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04596670 | Recruiting | Cancer |
Peking University Cancer Hospital & Institute|Peking University Health Science Center |
2024-09-20 | Early Phase 1 |
| NCT06160271 | Not yet recruiting | Non-alcoholic Steatohepatitis |
Central Hospital Nancy France |
2024-09-01 | Phase 2 |
| NCT06376253 | Not yet recruiting | Ovarian Cancer|Lung Cancer |
Novartis Pharmaceuticals|Novartis |
2024-09-06 | Phase 1 |
| NCT05170048 | Not yet recruiting | Non-Exudative (Dry) Age-related Macular Degeneration (dAMD) |
Evergreen Therapeutics Inc. |
2024-09 | Phase 2 |
| NCT06369831 | Not yet recruiting | Metastatic Breast Cancer |
ABSCINT NV/SA |
2024-08 | Phase 2 |
| NCT04495959 | Not yet recruiting | Prostatic Cancer |
British Columbia Cancer Agency |
2024-08 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).