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
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Name: ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Name: PF-06801591; RN-888
Drug: Axitinib
Dosed per package label starting with 5 mg PO BID
Other Name: AG-013736; Inlyta
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
- Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.
- Prior treatment with selective AXL/MERTK inhibitors
For participants receiving sasanlimab:
- Known history of non-infectious pneumonitis that required steroid treatment or current
pneumonitis.
Henry Eye Clinic
Fayetteville, Arkansas, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
UC Irvine Health
Orange, California, United States
UC Irvine Medical Center
Orange, California, United States
UCI Medical Center- Outpatient Pharmacy
Orange, California, United States
UCI/Chao Family Comprehensive Cancer Center
Orange, California, United States
Clinical & Translational Science Institute
San Francisco, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
San Francisco, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCSF Investigational Drugs Pharmacy
San Francisco, California, United States
Rocky Mountain Lions Eye Institute (RMLEI)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network Cancer Center North
Indianapolis, Indiana, United States
Community Health Network Investigational Drug Services
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Duke Eye Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
HPS Pharmacies Darlinghurst
Darlinghurst, New South Wales, Australia
Macquarie University
Macquarie University, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada
CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
Québec, Quebec, Canada
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Jilin Province Tumor Hospital
Changchun, Jilin, China
Azienda Ospedaliero Universitaria delle Marche
Ancona, AN, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Rome, Italy
Istituto Europeo di Oncologia IRCCS
Milano, Italy
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
Chayagasaka Eye Clinic
Nagoya, Aichi, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Aichi Cancer Center Hospital
Nagoya, Nagoya, Aichi, Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Asan Medical Center
Songpa-gu, Seoul-teukbyeolsi [seoul], Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Díaz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer