Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07265807 in participants with selected advanced or metastatic solid tumors.

Official Title

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Keywords

Neoplasm Metastasis TAMK (TAM kinase) MER (mer proto-oncogene) MERTK (mer proto-oncogene tyrosine kinase) AXL (AXL receptor tyrosine kinase) AXL/MER selective kinase inhibitor PD-1 (programmed cell death protein 1) PD-L1 (programmed cell death ligand 1) immune modulator

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants who are intolerant or resistant to standard treatment for selected solid tumors
  • at least one measurable or non-measurable lesion, not previously irradiated, as defined by RECIST 1.1
  • ECOG Performance Status 0 or 1, 2 with approval
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Resolved acute effects of any prior therapy

You CAN'T join if...

  • Known active uncontrolled or symptomatic CNS metastases
  • Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry
  • Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy
  • Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol
  • Retinal or other serious ophthalmic disorders as defined in protocol
  • Clinically significant cardiac disease as defined in protocol
  • Inability to consume or absorb study drug
  • Known or suspected hypersensitivity to PF-07265807
  • Prohibited concomitant medications as defined in protocol

Locations

  • UCI/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Rocky Mountain Lions Eye Institute (RMLEI) accepting new patients
    Aurora Colorado 80045 United States
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) accepting new patients
    Aurora Colorado 80045 United States
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) accepting new patients
    Aurora Colorado 80045 United States
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04458259
Phase
Phase 1
Study Type
Interventional
Last Updated