Batoprotafib (TNO155) Clinical Trials

Size	Price	Qty
2mg	USD 257
5mg	USD 470

Clinical Trials

Batoprotafib (TNO155) is evaluated in several Phase 1 and Phase 1/2 clinical trials testing monotherapy and combination regimens for advanced solid tumors, non-small cell lung cancer, colorectal cancer, melanoma, gastrointestinal stromal tumors, and KRAS G12C-mutated malignancies. Supported by pharmaceutical sponsors including Novartis, Mirati, and Amgen, alongside academic institutions like Massachusetts General Hospital, these studies encompass active, recruiting, terminated, and withdrawn statuses. Research also includes dedicated pharmacokinetic evaluations in patients with renal or hepatic impairment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07468071	RECRUITING	Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer; Advanced Solid Tumors Harboring the KRAS G12C Mutation	Novartis Pharmaceuticals	2026-06-08	PHASE1; PHASE2
NCT04699188	ACTIVE_NOT_RECRUITING	KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small-Cell Lung; Carcinoma, Colorectal; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms	Novartis Pharmaceuticals	2021-02-24	PHASE1; PHASE2
NCT04185883	ACTIVE_NOT_RECRUITING	Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation	Amgen	2019-12-17	PHASE1
NCT05541159	WITHDRAWN	Renal Impairment	Novartis Pharmaceuticals	2025-03-19	PHASE1
NCT03114319	TERMINATED	Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC); KRAS G12-mutant NSCLC; Esophageal Squamous Cell Cancer (SCC); Head/Neck SCC; Melanoma; Advanced Gastrointestinal Stromal Tumors (GIST); Advanced NRAS/BRAFT wt Cutaneous Melanoma	Novartis Pharmaceuticals	2017-05-26	PHASE1
NCT05490030	WITHDRAWN	Hepatic Impairment	Novartis Pharmaceuticals	2025-03-06	PHASE1
NCT05541159	Withdrawn	Renal Impairment	Novartis Pharmaceuticals\|Pharmaceutical Research Associates\|Novartis	2025-03-19	Phase 1
NCT05490030	Withdrawn	Hepatic Impairment	Novartis Pharmaceuticals\|Pharmaceutical Research Associates\|Novartis	2025-03-06	Phase 1
NCT04294160	TERMINATED	BRAF V600 Colorectal Cancer	Novartis Pharmaceuticals	2020-07-22	PHASE1
NCT04000529	TERMINATED	Non-small Cell Lung Carcinoma; Head and Neck Squamous Cell Carcinoma; Esophageal SCC; Gastrointestinal Stromal Tumors; Colorectal Cancer	Novartis Pharmaceuticals	2019-07-30	PHASE1
NCT04292119	UNKNOWN	Lung Cancer; Anaplastic Lymphoma Kinase Gene Translocation; ROS1 Rearrangement; Relapsed Cancer; MET Amplification; Resistant Cancer; NSCLC	Massachusetts General Hospital	2020-05-01	PHASE1; PHASE2
NCT04330664	COMPLETED	Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease	Mirati Therapeutics Inc.	2020-04-07	PHASE1
NCT04330664	Active not recruiting	Advanced Cancer\|Metastatic Cancer\|Malignant Neoplastic Disease	Mirati Therapeutics Inc.\|Novartis	2020-04-22	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Batoprotafib (TNO155) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Batoprotafib (TNO155) selectively inhibits protein tyrosine phosphatase non-receptor type 11 (SHP2/PTPN11), blocking receptor tyrosine kinase signaling and suppressing downstream RAS/MAPK pathway activation in cancer cells. By attenuating oncogenic signaling pathways necessary for cellular proliferation and survival, this compound demonstrates therapeutic relevance in treating advanced KRAS G12C-mutated solid tumors, non-small cell lung cancer, and colorectal carcinomas.

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>).