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
Brief 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

Recruiting
Neoplasm Metastasis

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Australia
Canada
China
Italy
Japan
Korea, Republic of
Spain
United States
Locations

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

Contacts

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
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
Advanced cancer
Metastatic cancer
Solid Tumor Cancer
Metastatic Solid Tumor
Cervical Cancer
gastric cancer
Esophageal Cancer
Endometrial Cancer
Hepatocellular carcinoma (HCC)
melanoma
Merkel Cell Carcinoma
High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor
Non-Small Cell Lung Cancer (NSCLC)
Small cell lung cancer (SCLC)
Renal cell carcinoma (RCC)
Urothelial carcinoma
Colorectal cancer (CRC)
MeSH Terms
Neoplasm Metastasis
Axitinib