Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3, sponsored by Jacobio Pharmaceuticals Co., Ltd. and Allist Pharmaceuticals, Inc., are evaluating JAB-3312 in KRAS G12C-mutated malignancies and various solid tumors. These investigations include completed early-phase evaluations as well as actively recruiting protocols across non-small cell lung, colorectal, pancreatic ductal, head and neck, esophageal, and breast cancers. Notably, an active Phase 3 trial is assessing JAB-3312 combination therapies specifically in advanced non-squamous non-small cell lung cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06416410 RECRUITING
Advanced Non-squamous Non-small-cell Lung Cancer; Metastatic Non-squamous Non Small Cell Lung Cancer
Allist Pharmaceuticals, Inc.
 2024-08-07 PHASE3
NCT05288205 RECRUITING
KRAS P.G12C; Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma
Allist Pharmaceuticals, Inc.
 2022-04-14 PHASE1; PHASE2
NCT04720976 COMPLETED
Solid Tumor; NSCLC
Allist Pharmaceuticals, Inc.
 2021-03-23 PHASE1; PHASE2
NCT04045496 COMPLETED
Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma; Esophageal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Other Solid Tumors
Jacobio Pharmaceuticals Co., Ltd.
 2019-09-26 PHASE1
NCT04121286 COMPLETED
Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma; Esophageal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Other Solid Tumors
Allist Pharmaceuticals, Inc.
 2020-07-14 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the JAB-3312 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JAB-3312 functions as a potent allosteric inhibitor of Src homology 2 domain-containing phosphatase 2 (SHP2) with an IC50 of 1.9 nM and a Kd of 0.37 nM, binding the enzyme to disrupt receptor tyrosine kinase-mediated RAS/MAPK signaling cascades and halt oncogenic cellular proliferation. By suppressing these hyperactive growth pathways, JAB-3312 suppresses tumor growth, demonstrating therapeutic relevance in clinical trial settings for solid malignancies including non-small cell lung cancer, colorectal cancer, and pancreatic ductal carcinoma.

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.