A Study of PF-07260437 in Advanced or Metastatic Solid Tumors
NCT ID: NCT05067972
Last Updated: 2025-05-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2021-10-07
2023-10-17
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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Monotherapy dose escalation (Part 1)
Participants will receive PF-07260437
PF-07260437
B7-H4 x CD3 bi-specific mAb
Dose Expansion (Part 2A) - Tumor specific Arm A
Participants will receive PF-07260437
PF-07260437
B7-H4 x CD3 bi-specific mAb
B7-H4 IHC
B7-H4 expression
Dose Expansion (Part 2B) - Tumor specific Arm B
Participants will receive PF-07260437
PF-07260437
B7-H4 x CD3 bi-specific mAb
B7-H4 IHC
B7-H4 expression
Dose Expansion (Part 2C) - Tumor specific Arm C
Participants will receive PF07260437
PF-07260437
B7-H4 x CD3 bi-specific mAb
B7-H4 IHC
B7-H4 expression
Interventions
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PF-07260437
B7-H4 x CD3 bi-specific mAb
B7-H4 IHC
B7-H4 expression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part 2A:In second line or more, participants with histological/cytological diagnosis of locally advanced or metastatic HR+ HER2- breast cancer showing high B7-H4 expression
* Part 2B: In second line or more participants with histological or cytological diagnosis of locally advance or metastatic HR+ Her2- breast cancer or triple negative breast cancer (TNBC) with no biomarker pre-selection
* Part 2C: In second line or more participants with histological diagnosis of locally advance or metastatic triple negative breast cancer with high B7-H4 expression
* Thyroid function within normal laboratory range; in participants with abnormal thyroid function if Free T4 is normal and participant is clinically euthyroid, participants is eligible
Exclusion Criteria
* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement).
* History of Grade ≥3 immune mediated adverse events (including liver function tests that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co stimulatory agents, etc.) and required immunosuppressive therapy within 1 year of treatment.
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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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Moffitt Cancer Center at McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
The University of Chicago Medicine Center of Advanced Care Orland Park
Orland Park, Illinois, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
NEXT Oncology
San Antonio, Texas, United States
Swedish Cancer Institute Edmonds Campus
Edmonds, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Mountlake
Seattle, Washington, United States
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
Pan American Center for Oncology Trials- Hospital Oncologico
Rio Piedras, , Puerto Rico
Pan American Center for Oncology Trials
Rio Piedras, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4431001
Identifier Type: -
Identifier Source: org_study_id
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