Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
NCT ID: NCT04628780
Last Updated: 2024-07-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
37 participants
INTERVENTIONAL
2020-12-16
2023-05-26
Brief Summary
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The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
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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 (Part 1)
Participants will receive PF-07209960 at escalating dose levels
PF-07209960
PD-1 targeted IL-15 mutein
Dose Expansion (Part 2) - Cohort 1 (NSCLC)
Participants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1
PF-07209960
PD-1 targeted IL-15 mutein
Dose Expansion (Part 2) - Cohort 2 (RCC)
Participants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
PF-07209960
PD-1 targeted IL-15 mutein
Dose Expansion (Part 2) - Cohort 3 (UC)
Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
PF-07209960
PD-1 targeted IL-15 mutein
Interventions
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PF-07209960
PD-1 targeted IL-15 mutein
Eligibility Criteria
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Inclusion Criteria
* Demonstrated radiographic progression on most recent tumor assessment imaging
* Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
* Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2
* Adequate hematologic, renal, liver, and coagulation functions
* LVEF ≥50% by echocardiogram or MUGA
* Resolved acute effects of any prior therapy
* Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy
* Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.
Exclusion Criteria
* Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Major surgery or radiation therapy within 4 weeks prior to planned first dose
* Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose
* Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
* Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible)
* Active COVID-19/SARS-CoV2
* Anticoagulation with vitamin K antagonists is not allowed
* Active bleeding disorder in the past 6 months prior to first dose
* History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
* History of interstitial lung disease or pneumonitis
* Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
* Pregnant or breastfeeding female participant
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 Investigational Drug Service (IDS)
Duarte, California, United States
City of Hope
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Christus Santa Rosa Hospital
San Antonio, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
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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2021-004587-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4011001
Identifier Type: -
Identifier Source: org_study_id
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