VS-7375 (GFH375) Clinical Trials

Size	Price	Qty
1mg	USD 290
5mg	USD 870

Clinical Trials

Multiple Phase 1, Phase 2, and Phase 3 clinical trials sponsored by Verastem, Inc. and Genfleet Therapeutics (Shanghai) Inc. are evaluating VS-7375 (GFH375) in patients with KRAS G12D-mutated advanced solid tumors, including non-small cell lung cancer, pancreatic ductal adenocarcinoma, and colorectal cancer. Evaluating both monotherapy and combination strategies, these studies assess the safety, pharmacokinetics, and therapeutic activity of the targeted agent. Trial recruitment statuses across the clinical development program currently range from actively recruiting and not yet recruiting to withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07668752	RECRUITING	KRAS G12D Mutation; NSCLC (Non-small Cell Lung Cancer)	Genfleet Therapeutics (Shanghai) Inc.	2026-07-27	PHASE3
NCT07020221	RECRUITING	Pancreatic Ductal Adenocarcinoma; Non Small Cell Lung Cancer; Colorectal Cancer; Solid Tumor, Adult; G12D Mutated KRAS	Verastem, Inc.	2025-06-24	PHASE1; PHASE2
NCT07784374	NOT_YET_RECRUITING	Pancreatic Cancer	Genfleet Therapeutics (Shanghai) Inc.	2026-08-31	PHASE2
NCT06500676	RECRUITING	KRAS G12D Mutations; Advanced Solid Tumors	Genfleet Therapeutics (Shanghai) Inc.	2024-07-09	PHASE1; PHASE2
NCT07026916	WITHDRAWN	Metastatic Pancreatic Cancer	Genfleet Therapeutics (Shanghai) Inc.	2025-08	PHASE2
NCT07259590	RECRUITING	Advanced Solid Tumors Cancer; PDAC; CRC (Colorectal Cancer)	Genfleet Therapeutics (Shanghai) Inc.	2025-10-21	PHASE1; PHASE2
NCT07659795	RECRUITING	Colorectal Cancer	Verastem, Inc.	2026-07-28	PHASE2
NCT07659782	RECRUITING	Non-Small Cell Lung Cancer	Verastem, Inc.	2026-07-22	PHASE2
NCT07644559	RECRUITING	Pancreatic Ductal Adenocarcinoma (PDAC); G12D Mutated KRAS	Verastem, Inc.	2026-06-16	PHASE2
NCT07262567	RECRUITING	Metastatic Pancreatic Cancer	Genfleet Therapeutics (Shanghai) Inc.	2025-12-04	PHASE3
NCT07554859	NOT_YET_RECRUITING	NSCLC (Advanced Non-small Cell Lung Cancer)	Genfleet Therapeutics (Shanghai) Inc.	2026-05-20	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-10)

Check the VS-7375 (GFH375) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VS-7375 selectively binds to both the active GTP-bound and inactive GDP-bound states of the KRAS G12D mutant, disrupting downstream oncogenic signaling cascades and suppressing tumor cell proliferation. This dual-state biochemical blockade leads to potent anti-tumor activity, mediating tumor regression in KRAS G12D-driven malignancies such as non-small cell lung cancer, colorectal cancer, and pancreatic ductal 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>).