A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
NCT ID: NCT06974734
Last Updated: 2026-01-15
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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ACTIVE_NOT_RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2025-05-06
2026-04-30
Brief Summary
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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.
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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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Part 1a
PF-08046037 monotherapy dose escalation
PF-08046037
Given into the vein (IV; intravenous)
Part 2a
PF-08046037 monotherapy dose optimization
PF-08046037
Given into the vein (IV; intravenous)
Part 3a
PF-08046037 monotherapy dose expansion
PF-08046037
Given into the vein (IV; intravenous)
Part 1b
PF-08046037 +sasanlimab dose escalation
PF-08046037
Given into the vein (IV; intravenous)
sasanlimab
Given under the skin (SQ; subcutaneous)
Part 2b
PF-08046037 + sasanlimab dose optimization
PF-08046037
Given into the vein (IV; intravenous)
sasanlimab
Given under the skin (SQ; subcutaneous)
Part 3b
PF-08046037 + sasanlimab dose expansion
PF-08046037
Given into the vein (IV; intravenous)
sasanlimab
Given under the skin (SQ; subcutaneous)
Interventions
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PF-08046037
Given into the vein (IV; intravenous)
sasanlimab
Given under the skin (SQ; subcutaneous)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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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Presbyterian/ St. Lukes Medical Center
Denver, Colorado, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States
Community Health Network, Inc
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
START Midwest
Grand Rapids, Michigan, United States
UPMC Vision Center
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Shadyside Hospital
Pittsburgh, Pennsylvania, 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
Methodist Hospital
San Antonio, Texas, United States
START San Antonio
San Antonio, Texas, United States
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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2025-521499-69-00
Identifier Type: CTIS
Identifier Source: secondary_id
C5941001
Identifier Type: -
Identifier Source: org_study_id
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