Clinical Trials

Multiple clinical trials across Phase II and Phase III evaluate fulzerasib in patients with KRAS G12C-mutated malignancies, specifically non-small cell lung cancer ranging from resectable early-stage to advanced or metastatic disease, colorectal cancer, and other solid tumors. Sponsored by academic institutions and corporate entities—such as Sun Yat-sen University, Shanghai Chest Hospital, Zhejiang University, and Shandong Suncadia Medicine Co., Ltd.—these protocols are currently in actively recruiting or not yet recruiting phases. Furthermore, several clinical trials are investigating neoadjuvant combination regimens within these patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07581912 RECRUITING
Colorectal Cancer; KRAS G12C Mutant Advanced Solid Tumors; Fulzerasib; Cetuximab N01
Zhejiang University
 2026-04-30 PHASE2
NCT07463677 NOT_YET_RECRUITING
Lung Cancer (NSCLC)
Sun Yat-sen University
 2026-03-15 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
NCT06936644 NOT_YET_RECRUITING
KRAS G12C Lung Cancer
Shanghai Chest Hospital
 2025-04-30 PHASE2
NCT07492342 RECRUITING
Resectable NSCLC; KRAS G12C Mutation; Stage IB-IIIA NSCLC; Neoadjuvant Therapy
Jianxing He
 2026-01-29 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fulzerasib is an irreversible small-molecule inhibitor that selectively binds to the KRAS G12C mutant protein, effectively blocking downstream mitogen-activated protein kinase signaling and ERK phosphorylation with an IC50 of 37 nM. This disruption suppresses oncogenic cell survival pathways to inhibit cellular proliferation, providing the mechanistic rationale for controlling tumor progression in KRAS G12C-driven non-small cell lung cancer and colorectal 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>).

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Note: Technical data last updated: Sep 1, 2026.