LY3214996 (Temuterkib) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple clinical trials spanning Early Phase 1 through Phase 2 evaluate LY3214996 as monotherapy and in combination regimens for healthy volunteers and patients with various malignancies, including pancreatic adenocarcinoma, colorectal cancer, non-small cell lung cancer, glioblastoma, acute myeloid leukemia, and MAPK pathway-mutated tumors. Sponsored by industry leaders like Eli Lilly and Company alongside major academic centers such as Dana-Farber Cancer Institute and M.D. Anderson Cancer Center, trial statuses encompass active, completed, terminated, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04616183	ACTIVE_NOT_RECRUITING	Metastatic Colon Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Recurrent Colorectal Carcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Colorectal Carcinoma; Unresectable Rectal Adenocarcinoma	M.D. Anderson Cancer Center	2020-12-02	PHASE1; PHASE2
NCT04916236	TERMINATED	Pancreatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer; KRAS Mutation-Related Tumors	The Netherlands Cancer Institute	2022-03-31	PHASE1
NCT04386057	COMPLETED	Pancreatic Cancer; Advanced Cancer	Kimberly Perez, MD	2020-05-27	PHASE2
NCT04534283	TERMINATED	Cancer; Cancer Metastatic; BRAF V600E; MEK1 Gene Mutation; MEK2 Gene Mutation; ERK Mutation; RAF1 Gene Mutation	Anita Turk	2020-10-05	PHASE2
NCT04081259	COMPLETED	Acute Myeloid Leukemia	Dana-Farber Cancer Institute	2020-07-15	PHASE1
NCT04391595	COMPLETED	Glioblastoma; GBM; Glioma	Nader Sanai	2020-07-11	EARLY_PHASE1
NCT04916236	Recruiting	Pancreatic Cancer\|Colorectal Cancer\|Non-small Cell Lung Cancer\|KRAS Mutation-Related Tumors	The Netherlands Cancer Institute\|Lustgarten Foundation	2022-03-31	Phase 1
NCT02857270	COMPLETED	Advanced Cancer; Metastatic Melanoma; Metastatic Non-small Cell Lung Cancer; Colorectal Cancer	Eli Lilly and Company	2016-09-29	PHASE1
NCT04043845	WITHDRAWN	Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia; Mantle Cell Lymphoma; Marginal Zone Lymphoma	Dana-Farber Cancer Institute	2020-02-03	PHASE1
NCT04033341	COMPLETED	Healthy	Eli Lilly and Company	2019-08-01	PHASE1
NCT04033341	Completed	Healthy	Eli Lilly and Company	2019-08-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the LY3214996 (Temuterkib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3214996 selectively binds to and inhibits extracellular signal-regulated kinases 1 and 2 (ERK1/2), blocking downstream phosphorylation of substrates such as RSK1 and disrupting oncogenic MAPK pathway signaling in RAS- or RAF-mutated cells. This biochemical inhibition suppresses tumor cell proliferation and survival, providing direct therapeutic relevance for clinical trials targeting KRAS- and BRAF-driven solid malignancies such as pancreatic, colorectal, and non-small cell lung cancers.

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>).