BBO-8520 Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

A clinical trial is currently evaluating the therapeutic potential of the oral compound BBO-8520, sponsored by industry sponsor BridgeBio Oncology Therapeutics. This open-label Phase 1a/1b study is actively recruiting patients with advanced or metastatic non-small cell lung cancer, as well as other advanced lung carcinomas driven by the KRAS G12C mutation. The trial aims to comprehensively assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BBO-8520 in affected patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06343402	RECRUITING	Non-small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer; NSCLC; KRAS G12C; Metastatic Lung Cancer; Advanced Lung Carcinoma	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)	2024-05-22	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the BBO-8520 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BBO-8520 covalently binds to GTP-bound KRAS G12C (ON) and promotes transition to the inactive (OFF) state, directly blocking the critical RAS-RAF1 protein interaction and downstream oncogenic signaling cascades. By effectively inhibiting cellular proliferation through this signaling block, the compound demonstrates therapeutic relevance in suppressing tumor progression in advanced and metastatic KRAS G12C-mutated 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>).