Clinical Trials

A clinical trial sponsored by Pfizer evaluated the safety, tolerability, and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors, including breast, prostate, pancreatic, liver, colorectal, and renal cell neoplasms, as well as squamous cell carcinoma, melanoma, and mesothelioma. Designed as an early-phase study to assess the compound across these diverse oncological conditions, its recruitment status is recorded as terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03685591 TERMINATED
Breast Neoplasms; Prostate Neoplasms; Neoplasms, Squamous Cell; Melanoma; Mesothelioma; Pancreatic Neoplasms; Colorectal Neoplasms; Carcinoma, Renal Cell; Liver Neoplasms
Pfizer
 2018-10-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-06-26)

Check the PF-06952229 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06952229 selectively binds to and inhibits transforming growth factor-beta receptor 1 (TGF-β-R1), preventing the phosphorylation of SMAD2 and blocking downstream signaling cascades. This molecular inhibition suppresses epithelial-mesenchymal transition and alters the tumor immune microenvironment, thereby impairing growth and invasion in solid malignancies such as breast, prostate, and pancreatic neoplasms.

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.