Avutometinib (Ro5126766, CH5126766) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 597

Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 3, evaluate avutometinib as a monotherapy and in combination regimens for malignancies including KRAS-mutant non-small cell lung cancer, pancreatic adenocarcinoma, thyroid cancer, low-grade serous ovarian cancer, and pediatric central nervous system tumors. Sponsored by pharmaceutical entities such as Verastem, Inc. and academic institutions including Memorial Sloan Kettering Cancer Center, these studies encompass active, recruiting, and completed stages. Ultimately, these evaluations aim to establish the efficacy and safety profile of avutometinib across refractory and advanced neoplastic conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07743554	NOT_YET_RECRUITING	MPNST (Malignant Peripheral Nerve Sheath Tumor)	Girish Dhall, MD	2027-01-01	PHASE2
NCT07126158	RECRUITING	Pancreatic Adenocarcinoma; Cancer of the Pancreas; Pancreas Cancer; Pancreatic Cancer	Washington University School of Medicine	2026-04-10	PHASE2
NCT06104488	ACTIVE_NOT_RECRUITING	Refractory Cancer; CNS Tumors; CNS Tumor, Adult; CNS Tumor, Childhood; MAP Kinase Family Gene Mutation; NF1; Plexiform Neurofibroma; Low-grade Glioma; Optic Pathway Gliomas; Neuroblastoma; Primary Brain Tumor; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; Central Nervous System Tumor	Memorial Sloan Kettering Cancer Center	2023-10-20	PHASE1
NCT06630260	RECRUITING	Glioblastoma Multiforme (GBM); Glioblastoma Multiform (Grade IV Astrocytoma); Diffuse Hemispheric Glioma, H3 G34-Mutant; Malignant Primary Gliomas	Institute of Cancer Research, United Kingdom	2024-11-15	PHASE1; PHASE2
NCT06495125	RECRUITING	Advanced Lung Adenocarcinoma; Refractory Lung Adenocarcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8	Emory University	2024-07-31	PHASE2
NCT06369259	RECRUITING	Advanced Colorectal Cancer	M.D. Anderson Cancer Center	2025-02-24	PHASE2
NCT06487221	RECRUITING	Gastric Cancer; Stomach Cancer	Ryan H. Moy, MD, PhD	2024-10-28	PHASE2
NCT07778602	NOT_YET_RECRUITING	MGMT-unmethylated Glioblastoma (GBM); IDH Wildtype Glioblastoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2026-11-10	EARLY_PHASE1
NCT06072781	RECRUITING	Low Grade Serous Ovarian Cancer	Verastem, Inc.	2024-03-18	PHASE3
NCT07318324	RECRUITING	Phase IB; Avutometinib; RAS Pathway; Endometrial	M.D. Anderson Cancer Center	2026-05-13	PHASE1
NCT06194929	RECRUITING	Cutaneous Melanoma; Brain Metastases	University of Utah	2024-03-20	PHASE1; PHASE2
NCT05608252	RECRUITING	Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer	Adrienne G. Waks	2023-02-23	PHASE1; PHASE2
NCT05512208	RECRUITING	Endometrioid Cancer; Mucinous Ovarian Cancer; High Grade Serous Ovarian Cancer; Cervical Cancer; Solid Tumor	University of Oklahoma	2023-02-06	PHASE2
NCT06007924	RECRUITING	Thyroid Cancer	Memorial Sloan Kettering Cancer Center	2023-08-16	PHASE2
NCT07747506	NOT_YET_RECRUITING	Low Grade Ovarian Serous Adenocarcinoma; Ovarian Cancer	Verastem, Inc.	2026-08-03	PHASE2
NCT05200442	SUSPENDED	Colorectal Cancer; Colorectal Adenocarcinoma; Colorectal Cancer Metastatic; Advanced Colorectal Carcinoma; Advanced Colorectal Adenocarcinoma	University of Chicago	2022-08-22	PHASE1; PHASE2
NCT06394804	RECRUITING	Low-Grade Serous Ovarian Cancer	Memorial Sloan Kettering Cancer Center	2024-04-29	PHASE2
NCT05787561	RECRUITING	Mesonephric Gynecologic Cancer	Memorial Sloan Kettering Cancer Center	2023-03-15	PHASE2
NCT05798507	ACTIVE_NOT_RECRUITING	Glioblastoma; Recurrent Glioblastoma	Emory University	2023-07-28	EARLY_PHASE1
NCT05669482	ACTIVE_NOT_RECRUITING	KRAS Activating Mutation; Metastatic Cancer; Pancreas Cancer; Neoplasms Pancreatic; Malignant Neoplasm of Pancreas	Verastem, Inc.	2023-03-22	PHASE1; PHASE2
NCT05375994	COMPLETED	Non Small Cell Lung Cancer; KRAS Activating Mutation; Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung; Malignant Neoplastic Disease	Verastem, Inc.	2022-08-01	PHASE1; PHASE2
NCT05074810	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer; KRAS Activating Mutation	Verastem, Inc.	2022-04-12	PHASE1; PHASE2
NCT06682572	ACTIVE_NOT_RECRUITING	Low Grade Serous Ovarian Cancer; Ovarian Cancer	Verastem, Inc.	2024-10-30	PHASE2
NCT04625270	ACTIVE_NOT_RECRUITING	Low Grade Ovarian Serous Adenocarcinoma; Ovarian Cancer	Verastem, Inc.	2020-12-21	PHASE2
NCT06104488	Recruiting	Refractory Cancer\|CNS Tumors\|CNS Tumor Adult\|CNS Tumor Childhood\|MAP Kinase Family Gene Mutation\|NF1\|Plexiform Neurofibroma\|Low-grade Glioma\|Optic Pathway Gliomas\|Neuroblastoma\|Primary Brain Tumor\|Solid Tumor\|Solid Tumor Adult\|Solid Carcinoma\|Central Nervous System Tumor	Memorial Sloan Kettering Cancer Center	2023-10-20	Phase 1
NCT04620330	COMPLETED	Non Small Cell Lung Cancer; KRAS Activating Mutation	Verastem, Inc.	2020-12-31	PHASE2
NCT05375994	Recruiting	Non Small Cell Lung Cancer\|KRAS Activating Mutation\|Advanced Cancer\|Metastatic Cancer\|Malignant Neoplasm of Lung\|Malignant Neoplastic Disease	Verastem Inc.\|Mirati Therapeutics Inc.	2022-08-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-04)

Check the Avutometinib (Ro5126766, CH5126766) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avutometinib functions as a dual RAF/MEK inhibitor that potently targets BRAF, CRAF, and MEK1, suppressing downstream MAPK/ERK pathway signaling within hyperactive cancer cells. By disrupting this central kinase cascade, the compound arrests cell cycle progression and impairs cell survival, thereby inhibiting tumor growth in clinical contexts such as KRAS-mutant non-small cell lung cancer and pancreatic adenocarcinoma.

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>).