Clinical Trials

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statuses across these investigations vary, encompassing completed studies, active non-recruiting trials, and withdrawn protocols.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NCT04158700 WITHDRAWN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NCT04031872 WITHDRAWN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NCT04158700 Withdrawn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)

Check the LY 3200882 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY 3200882 functions as a potent and selective inhibitor of TGF-β receptor type 1 (TGFβRI), binding the receptor to block downstream TGF-β-mediated SMAD phosphorylation. This disruption suppresses immunosuppressive signaling in tumor and immune cells, inhibiting tumor growth in clinical contexts such as advanced solid tumors and metastatic colorectal cancer.

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.