Clinical Trials

The clinical development landscape for PF-07265807 includes a clinical trial sponsored by Pfizer to evaluate the safety, tolerability, pharmacokinetics, and dosing of the agent in adult patients with neoplasm metastasis. Although designed as a Phase 1 open-label study for advanced metastatic malignancies, recruitment was ultimately terminated. Consequently, available human clinical data for PF-07265807 remain restricted to this early-phase evaluation, underscoring a continued reliance on preclinical findings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04458259 TERMINATED
Neoplasm Metastasis
Pfizer
2020-09-24 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-04)

Check the PF-07265807 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-07265807 acts as a dual receptor tyrosine kinase inhibitor targeting AXL and MER, thereby blocking downstream oncogenic signaling cascades and enhancing the capacity of dendritic cells to cross-prime CD8+ cytotoxic T lymphocytes. This simultaneous inhibition of immunosuppressive signaling and stimulation of anti-tumor immunity suppresses tumor cell proliferation and dissemination, highlighting its therapeutic potential against neoplasm metastasis.

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>).

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