Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
NCT ID: NCT04152018
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
85 participants
INTERVENTIONAL
2019-11-13
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Single Agent Dose Escalation
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
Dose Finding Anti-PD-1 Combination 1
Part 1B PF-06940434 plus anti-PD-1
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Dose Expansion Arm A
PF-06940434 with anti-PD-1 in SCCHN
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Dose Expansion Arm B
PF-06940434 with anti-PD-1 in RCC
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Dose Expansion, Arm C
PF-06940434 with anti-PD-1 (both Q3W)
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Interventions
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PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Part 2:
* Arm A SCCHN:
* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
* PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
* Arm B RCC (clear cell):
* 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
* Adequate bone marrow, kidney and liver function.
* Performance status of 0 or 1.
Exclusion Criteria
* Hypertension that cannot be controlled by medications.
* Active or prior autoimmune disease
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology Oncology
Los Angeles, California, United States
UCLA Hematology/Oncology
Santa Monica, California, United States
Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Duke Univ. Medical Center/Duke Cancer Center
Durham, North Carolina, United States
Investigational Chemotherapy Service
Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Narodny ustav srdcovych a cievnych chorob, a.s.
Bratislava, , Slovakia
MR Poprad s.r.o.
Komárno, , Slovakia
KARDIO, s.r.o.
Poprad, , Slovakia
POKO Poprad, s.r.o., Ambulancia klinickej onkologie
Poprad, , Slovakia
Nemocnica Poprad a.s.
Poprad, , Slovakia
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-004009-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3891001
Identifier Type: -
Identifier Source: org_study_id
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