BBP- 398 (IACS-13909) Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

Multiple clinical trials evaluate BBP-398 across oncology indications, specifically focusing on advanced solid tumors and non-small cell lung cancer (NSCLC). Sponsored by industry entities such as Navire Pharma, LianBio, Bristol-Myers Squibb, and Amgen, these early-phase studies assess BBP-398 both as monotherapy and in combination with sotorasib, osimertinib, or nivolumab. Current protocol statuses across these investigations include recruiting, active not recruiting, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05480865	TERMINATED	Solid Tumor, Adult; Metastatic Solid Tumor; Metastatic NSCLC; Non Small Cell Lung Cancer	Navire Pharma Inc., a BridgeBio company	2022-07-06	PHASE1
NCT05375084	TERMINATED	Non Small Cell Lung Cancer; Solid Tumor	Navire Pharma Inc., a BridgeBio company	2022-10-20	PHASE1
NCT06032936	TERMINATED	NSCLC	LianBio LLC	2023-07-27	PHASE1
NCT05621525	TERMINATED	Advanced Solid Tumor; Advanced or Metastatic Non-small Cell Lung Cancer	LianBio LLC	2022-10-18	PHASE1
NCT04528836	TERMINATED	Tumor, Solid	Navire Pharma Inc., a BridgeBio company	2020-11-12	PHASE1
NCT05621525	Recruiting	Advanced Solid Tumor\|Advanced or Metastatic Non-small Cell Lung Cancer	LianBio LLC	2022-10-18	Phase 1
NCT05375084	Recruiting	Non Small Cell Lung Cancer\|Solid Tumor	Navire Pharma Inc. a BridgeBio company\|Bristol-Myers Squibb	2022-10-20	Phase 1
NCT05480865	Recruiting	Solid Tumor Adult\|Metastatic Solid Tumor\|Metastatic NSCLC\|Non Small Cell Lung Cancer	Navire Pharma Inc. a BridgeBio company\|Amgen	2022-07-06	Phase 1
NCT04528836	Active not recruiting	Tumor Solid	Navire Pharma Inc. a BridgeBio company	2020-11-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-12-12)

Check the BBP- 398 (IACS-13909) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BBP-398 functions as a potent allosteric inhibitor of Src homology 2 domain-containing phosphatase (SHP2), binding selectively to block downstream signal transduction through the mitogen-activated protein kinase (MAPK) pathway. This biochemical inhibition suppresses cellular proliferation and survival signaling, driving antitumor activity relevant to clinical evaluation in advanced solid tumors and 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>).