Esophageal Cancer Clinical Trial

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

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

View Eligibility Criteria

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 immunotherapy-drugs-are-boosting-survival/" >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.

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

- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

161

Study ID:

NCT04458259

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 26 Locations for this study

See Locations Near You

Henry Eye Clinic
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
UCI Medical Center- Outpatient Pharmacy
Orange California, 92868, United States
UCI/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Clinical & Translational Science Institute
San Francisco California, 94158, United States
UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
San Francisco California, 94158, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
UCSF Investigational Drugs Pharmacy
San Francisco California, 94158, United States
Rocky Mountain Lions Eye Institute (RMLEI)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora Colorado, 80045, United States
Community Health Network, Inc.
Indianapolis Indiana, 46219, United States
Community Health Network, Inc.
Indianapolis Indiana, 46227, United States
Community Health Network Cancer Center North
Indianapolis Indiana, 46250, United States
Community Health Network Investigational Drug Services
Indianapolis Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis Indiana, 46256, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Duke Eye Center
Durham North Carolina, 27705, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The University of Texas M. D. Anderson Cancer Center
Houston Texas, 77030, United States
Macquarie University
Macquarie University New South Wales, 2109, Australia
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada
University Health Network
Toronto Ontario, M5G 2, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Quebec City Quebec, G1J 1, Canada
CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
Québec Quebec, G1R 2, Canada
Istituto Europeo di Oncologia IRCCS
Milano , 20141, Italy
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Fundacion Jimenez Díaz
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

161

Study ID:

NCT04458259

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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