Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 are evaluating BGB 15025 in oncology, sponsored by BeiGene and BeOne Medicines with recruitment statuses ranging from recruiting and active non-recruiting to completed. Research focuses on advanced solid tumors, advanced malignancies, and non-small cell lung cancer, including metastatic disease. Early-stage studies assess safety, tolerability, pharmacokinetics, and preliminary efficacy, whereas later-phase protocols investigate BGB 15025 combination regimens in advanced non-small cell lung cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04164199 COMPLETED
Advanced Malignancies
BeOne Medicines
 2019-12-19 PHASE3
NCT05635708 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer; Metastatic Non-small Cell Lung Cancer
BeiGene
 2023-03-07 PHASE2
NCT04649385 COMPLETED
Advanced Solid Tumor
BeiGene
 2021-03-04 PHASE1
NCT06029127 COMPLETED
Non-Small Cell Lung Cancer
BeiGene
 2023-10-23 PHASE2
NCT04649385 Recruiting
Advanced Solid Tumor
BeiGene
 2021-03-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the BGB 15025 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BGB-15025 selectively binds to and inhibits hematopoietic progenitor kinase 1 (HPK1), blocking downstream HPK1-mediated signal transduction pathways and reversing immune cell exhaustion within the tumor microenvironment. By augmenting T-cell activation and immune response against cancer cells, this target inhibition suppresses tumor progression 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>).

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