Glecirasib Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Multiple clinical trials evaluate the efficacy, safety, and therapeutic combinations of glecirasib across Phase 1, Phase 2, and Phase 3 studies for KRAS G12C-mutated non-small cell lung cancer spanning locally advanced, stage III, and metastatic stage IV disease. Sponsored by biopharmaceutical companies and academic medical centers, these protocols investigate glecirasib as both monotherapy and combination therapy, including regimens with ABSK043. Current recruitment statuses across the trial portfolio range from active recruiting to not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07164170	RECRUITING	Non-Small Cell Lung Cancer	Abbisko Therapeutics Co, Ltd	2025-09-22	PHASE2
NCT07601048	NOT_YET_RECRUITING	KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment	Shandong Suncadia Medicine Co., Ltd.	2026-06	PHASE3
NCT07670013	RECRUITING	NSCLC	Second Affiliated Hospital, Zhejiang University, School of Medicine	2026-04-01	PHASE2
NCT06563999	RECRUITING	Lung Cancer Stage III; Mutation	Sun Yat-sen University	2024-11-01	PHASE2
NCT07339839	NOT_YET_RECRUITING	NSCLC Stage IV; KRAS G12C	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2026-03-01	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glecirasib is a potent, covalent inhibitor that selectively binds to the mutant cysteine residue of inactive GDP-bound KRAS G12C, locking the protein in an inactive conformation and preventing downstream MAPK pathway signaling. This biochemical blockade disrupts cell proliferation and survival cascades, ultimately suppressing tumor growth in KRAS G12C-mutated non-small cell lung 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>).