Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Adil Daud
Photo of Adil Daud
Adil Daud

Description

Summary

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with 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 Axitinib Sasanlimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), 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
  • Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
  • Life expectancy of at least 3 months.
  • Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
  • Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
  • Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
  • Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.

You CAN'T join if...

  • Known active uncontrolled or symptomatic CNS metastases.
  • Any other active malignancy within 2 years prior to enrollment.
  • 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.
  • Uncontrolled HTN that cannot be controlled by medications.
  • Inability to consume or absorb study drug.
  • Known or suspected hypersensitivity to PF-07265807.
  • Prohibited concomitant medications as defined in protocol.
  • Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
  • Active bleeding disorder.

For Part 2, Part 3, and Part 4, Cohorts 2-4:

  • Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
  • Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
  • Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall not yet accepting patients
    San Francisco California 94158 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco California 94158 United States
  • UCSF Investigational Drugs Pharmacy not yet accepting patients
    San Francisco California 94158 United States
  • Clinical & Translational Science Institute not yet accepting patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Adil Daud
    Professor, Medicine. Authored (or co-authored) 183 research publications.

Details

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