Multiple completed clinical trials sponsored by Memorial Sloan Kettering Cancer Center and Esperas Pharma Inc. have evaluated the safety and therapeutic potential of LY2880070 across Phase 1 and Phase 2. A Phase 2 study investigated LY2880070 combined with low-dose gemcitabine in patients with relapsed or refractory Ewing sarcoma and Ewing-like sarcoma. Additionally, a Phase 1b/2a trial evaluated the compound as monotherapy and combination therapy across solid tumors, including colorectal, pancreatic, endometrial, ovarian, and triple-negative breast cancers.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05275426 | COMPLETED | Ewing Sarcoma; Ewing-Like Sarcoma |
Memorial Sloan Kettering Cancer Center |
2022-03-02 | PHASE2 |
| NCT02632448 | COMPLETED | Solid Tumors; Colorectal Cancer; Breast Cancer; Ovarian Cancer; Colon Cancer; Rectal Cancer; Neoplasms; Endometrial Cancer; Soft Tissue Sarcoma; Triple Negative Breast Cancer; Pancreas Cancer; Pancreatic Cancer |
Esperas Pharma Inc. |
2016-05-16 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-08-15)
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>).