BBO-10203 Clinical Trials

Size	Price	Qty
1mg	USD 1,590
5mg	USD 4,770

Clinical Trials

Several clinical trials sponsored by BridgeBio Oncology Therapeutics (TheRas, Inc.) are actively recruiting adult patients to evaluate novel oncology therapeutics, including BBO-10203. These early-stage, open-label Phase 1 and Phase 1a/1b studies assess safety, tolerability, pharmacokinetics, and clinical efficacy. Target indications encompass advanced solid tumors, including non-small cell lung cancer, KRAS-mutated colorectal cancer, pancreatic ductal adenocarcinoma, and HER2- or HR-defined breast malignancies.

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
NCT06625775	RECRUITING	Solid Tumor, Adult; Metastatic Breast Cancer; Advanced Breast Cancer; HER2 Mutation-Related Tumors; HER2-positive Metastatic Breast Cancer; KRAS Mutant Metastatic Colorectal Cancer; Metastatic Lung Cancer; Metastatic Colorectal Cancer; Advanced Lung Cancer; HR-positive, HER2-negative Advanced Breast Cancer; HER2-positive Advanced Breast Cancer	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)	2024-10-29	PHASE1
NCT06917079	RECRUITING	Non-Small Cell Lung Cancer; NSCLC; PDAC - Pancreatic Ductal Adenocarcinoma; CRC (Colorectal Cancer); Metastatic Non-Small Lung Cell Cancer; Metastatic Colorectal Cancer (CRC); KRAS G12A; KRAS G12C; KRAS G12D; KRAS G12S; KRAS G12V; Metastatic Pancreatic Ductal Adenocarcinoma; Advanced Lung Carcinoma; Solid Tumor, Adult	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)	2025-03-31	PHASE1

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

Check the BBO-10203 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BBO-10203 covalently binds to Cys242 within the PI3Kα RAS-binding domain to disrupt the RAS-PI3Kα interaction, thereby suppressing downstream RAS-dependent PI3Kα activation and decreasing pERK levels to induce G1 phase cell cycle arrest and apoptosis. This dual inhibition of PI3Kα and KRASG12C signaling blocks tumor cell proliferation, providing a mechanistically targeted approach for treating advanced solid tumors, including non-small cell lung, colorectal, and breast cancers under active clinical investigation.

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>).