A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
NCT ID: NCT06285097
Last Updated: 2025-09-17
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
9 participants
INTERVENTIONAL
2024-02-08
2025-02-13
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 1A)
Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles
PF-07820435
immune agonist
Combination dose escalation (Part 1B)
Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles
PF-07820435
immune agonist
Sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Expansion (Part 2) - Tumor specific Arm A
Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles
PF-07820435
immune agonist
Sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Expansion (Part 2) - Tumor specific Arm B
Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles
PF-07820435
immune agonist
Sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Expansion (Part 2) - Arm C
Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles
PF-07820435
immune agonist
Interventions
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PF-07820435
immune agonist
Sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Eligibility Criteria
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Inclusion Criteria
* Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
* Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
* Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
* At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
* Able to provide pre-treatment (and optional on-treatment) tumor tissue
Exclusion Criteria
* Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
* Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
* History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy
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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Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, United States
Corewell Health (reference non-engagement letter)
Grand Rapids, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tristar Centennial Medical Center
Nashville, Tennessee, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, , Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
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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NCT06285097
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5391001
Identifier Type: -
Identifier Source: org_study_id
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