ASN007 Clinical Trials

Size	Price	Qty
5mg	USD 319
25mg	USD 957

Clinical Trials

ASN007 (ERAS-007) is being evaluated across multiple Phase 1 and Phase 1/2 clinical trials for advanced or metastatic solid malignancies, including melanoma, non-small cell lung cancer, colorectal cancer, and pancreatic adenocarcinoma. Industry sponsors Asana BioSciences and Erasca Inc. have conducted these studies, which encompass completed dose-finding trials as well as active, non-recruiting evaluations of monotherapy and combination regimens. Overall, these investigations assess safety, dosage, and preliminary efficacy to establish the therapeutic utility of targeting the MAPK pathway in refractory tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04866134	Active not recruiting	Advanced or Metastatic Solid Tumors	Erasca Inc.	2021-05-07	Phase 1\|Phase 2
NCT03415126	COMPLETED	Cancer; Malignancy; Neoplasia; Neoplasm; Neoplasm Metastasis; Colon Cancer; Colonic Neoplasms; Colon Cancer Liver Metastasis; Metastatic Cancer; Metastatic Melanoma; Metastatic Colon Cancer; Metastatic Lung Cancer; Non Small Cell Lung Cancer Metastatic; Pancreatic Cancer; Pancreas Cancer; Pancreas Adenocarcinoma; Pancreas Neoplasm; Metastatic Nonsmall Cell Lung Cancer; Metastatic Pancreatic Cancer	Asana BioSciences	2018-01-19	PHASE1
NCT03415126	Completed	Cancer\|Malignancy\|Neoplasia\|Neoplasm\|Neoplasm Metastasis\|Colon Cancer\|Colonic Neoplasms\|Colon Cancer Liver Metastasis\|Metastatic Cancer\|Metastatic Melanoma\|Metastatic Colon Cancer\|Metastatic Lung Cancer\|Non Small Cell Lung Cancer Metastatic\|Pancreatic Cancer\|Pancreas Cancer\|Pancreas Adenocarcinoma\|Pancreas Neoplasm\|Metastatic Nonsmall Cell Lung Cancer\|Metastatic Pancreatic Cancer	Asana BioSciences	2018-01-19	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the ASN007 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ASN007 acts as a potent inhibitor that selectively binds to extracellular signal-regulated kinases 1 and 2 (ERK1/2) with an IC50 of 2 nM, effectively blocking downstream phosphorylation events within the MAPK signaling cascade. This biochemical inhibition disrupts oncogenic signal transduction to induce cell cycle arrest and apoptosis, thereby suppressing tumor growth in patients with advanced or metastatic 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>).