A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 17, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: PF-07820435; Biological: Sasanlimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
- 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
- Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Florida Cancer Specialists Sarasota Drug Development UnitSarasota, Florida
- Corewell Health (reference non-engagement letter)Grand Rapids, Michigan
- START MidwestGrand Rapids, Michigan
- Sarah Cannon Research Institute - PharmacyNashville, Tennessee
- SCRI Oncology PartnersNashville, Tennessee
- Tristar Centennial Medical CenterNashville, Tennessee
- National Cancer Center Hospital EastKashiwa, Chiba
- The Cancer Institute Hospital of JFCRKoto, Tokyo
- Hospital Oncologico Dr. Isaac Gonzalez-MartinezRio Piedras
- Pan American Center for Oncology Trials, LLCRio Piedras
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2025. Always confirm current availability with the study team.