Clinical Trials

Sponsored by Jacobio Pharmaceuticals Co., Ltd., several clinical trials have evaluated the therapeutic potential of JAB-3068 in advanced solid tumors, non-small cell lung cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma. The clinical development pipeline encompasses Phase I dose-escalation studies alongside Phase I/II and Phase Ib/IIa safety, tolerability, and pharmacokinetic evaluations. All of these trials have achieved completed recruitment status, establishing key clinical parameters for this compound across these metastatic solid tumor indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04721223 COMPLETED
Advanced Solid Tumor; Esophageal Squamous Cell Carcinoma; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma
Jacobio Pharmaceuticals Co., Ltd.
 2021-04-26 PHASE1; PHASE2
NCT03565003 COMPLETED
Non-small Cell Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Other Metastatic Solid Tumors
Jacobio Pharmaceuticals Co., Ltd.
 2018-11-20 PHASE1; PHASE2
NCT03518554 COMPLETED
Non-small Cell Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Other Metastatic Solid Tumors
Jacobio Pharmaceuticals Co., Ltd.
 2018-04-23 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-09-19)

Check the JAB-3068 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JAB-3068 functions as a potent allosteric inhibitor of Src homology 2 domain-containing phosphatase 2 (SHP2), selectively binding the enzyme to suppress downstream RAS/MAPK signaling cascades. By inhibiting SHP2 activation, the compound restores CD8+ T-cell anti-tumor immunity and promotes tumor growth inhibition, providing a strong mechanistic rationale for targeting non-small cell lung cancer, esophageal carcinoma, and other advanced solid tumors.

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>).

Jump to

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