Clinical Trials

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)

Check the LY2880070 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2880070 selectively binds to and inhibits checkpoint kinase 1 (CHK1), which disrupts DNA damage checkpoint signalling and prevents cancer cells from repairing DNA lesions. This failure of checkpoint arrest forces compromised cells into premature and uncoordinated mitosis, inducing mitotic catastrophe and programmed cell death to inhibit tumor growth in clinical indications such as Ewing sarcoma and various advanced solid tumors.

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>).

Note: Technical data last updated: Sep 1, 2026.