A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies. This study is seeking participants who: * have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC); * are able to provide tumor tissue samples; * have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
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 Apr 23, 2026 · 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-08046037; Drug: 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.
- This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below. 1. Tumor types
- Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts
- Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC
- Must have progressive disease following at least 1 prior approved systemic therapy
- Monotherapy Dose Expansion (Part 3a)
- Advanced or metastatic NSCLC or PDAC
- Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)
- Advanced or metastatic NSCLC or HNSCC
- May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy
- Combination Dose Expansion (Part 3b)
- Unresectable locally advanced or metastatic HNSCC or NSCLC
- Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting)
- Must be treatment naïve to any immunotherapy
- NSCLC must have PD-L1 expression TPS \>=50%
- HNSCC must have PD-L1 expression CPS \>=1 2. Tissue requirement
- Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory
- Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment
- Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required
- Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment
- Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor 3. Measurable disease per RECIST v1.1 Participants who meet the following might not be able to participate. 1. History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy 2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent 3. History of uveitis within the preceding 6 months 4. Clinically significant Grade \>=3 neurodegenerative disease 5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy 6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Presbyterian/ St. Lukes Medical CenterDenver, Colorado
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Smilow Cancer Hospital - Yale New Haven HealthNew Haven, Connecticut
- Yale - New Haven Hospital - Yale Cancer CenterNew Haven, Connecticut
- Smilow Cancer Hospital Phase 1 UnitNew Haven, Connecticut
- Smilow Cancer Hospital - TrumbullTrumbull, Connecticut
- Community Health Network, IncIndianapolis, Indiana
- Community Health Network, Inc.Indianapolis, Indiana
- Community Health Network, Inc.Indianapolis, Indiana
- Community Health Network, Inc.Indianapolis, Indiana
- START MidwestGrand Rapids, Michigan
- Sarah Cannon Research Institute - PharmacyNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 23, 2026. Always confirm current availability with the study team.