LY 3200882 has been evaluated across several clinical trials, encompassing Phase 1 and Phase 1/2 studies for solid tumors, metastatic colorectal cancer, advanced cancer, and pharmacokinetic evaluations in healthy volunteers. The clinical program involves major industry sponsors, including Eli Lilly and Company and Merck Sharp & Dohme LLC, alongside academic networks such as The Netherlands Cancer Institute and the EORTC. Recruitment statuses across these investigations vary, encompassing completed studies, active non-recruiting trials, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04158700 | WITHDRAWN | Advanced Cancer |
Eli Lilly and Company |
2019-12-05 | PHASE1; PHASE2 |
| NCT02937272 | ACTIVE_NOT_RECRUITING | Solid Tumor |
Eli Lilly and Company |
2016-11-21 | PHASE1 |
| NCT04031872 | Unknown status | Colorectal Cancer Metastatic |
The Netherlands Cancer Institute|Vall d''Hebron Institute of Oncology|Agendia|European Organisation for Research and Treatment of Cancer - EORTC|Azienda Ospedaliera Niguarda Cà Granda|Fundación para la Investigación del Hospital Clínico de Valencia|University of Campania Luigi Vanvitelli|University of Turin Italy|Eli Lilly and Company|Catalan Institute of Health|Universitaire Ziekenhuizen KU Leuven |
2020-02 | Phase 1|Phase 2 |
| NCT04031872 | WITHDRAWN | Colorectal Cancer Metastatic |
The Netherlands Cancer Institute |
2020-01-01 | PHASE1; PHASE2 |
| NCT04158700 | Withdrawn | Advanced Cancer |
Eli Lilly and Company|Merck Sharp & Dohme LLC |
2019-12-05 | Phase 1|Phase 2 |
| NCT03792139 | COMPLETED | Healthy |
Eli Lilly and Company |
2019-01-08 | PHASE1 |
| NCT03792139 | Completed | Healthy |
Eli Lilly and Company |
2019-01-08 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2020-02-19)
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>).