Pfizer's new cancer drug combo tested in tiny early trial
NCT ID NCT06974734
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested a new drug called PF-08046037, alone or with another drug (sasanlimab), in 8 people with advanced lung, pancreatic, melanoma, or head & neck cancers. The goal was to check safety and how the body handles the drugs. The trial was terminated early, so results are very limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08046037 (also called SGN-PDL1iT) and sasanlimab
- What this could lead to
- If it works, this could point toward a new treatment option for certain advanced cancers that have stopped responding to other therapies.
- What could go wrong
- This was a very early Phase 1 trial with only 8 participants, and it was terminated early. It is too small and preliminary to know if the drug is safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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May 2025
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Community Health Network, Inc
Indianapolis, Indiana, 46219, United States
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Community Health Network, Inc.
Indianapolis, Indiana, 46227, United States
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Community Health Network, Inc.
Indianapolis, Indiana, 46250, United States
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Community Health Network, Inc.
Indianapolis, Indiana, 46256, United States
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Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
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Presbyterian/ St. Lukes Medical Center
Denver, Colorado, 80218, United States
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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START Midwest
Grand Rapids, Michigan, 49546, United States
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Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
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Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611, United States
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Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510, United States
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Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511, United States
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Tristar Centennial Medical Center
Nashville, Tennessee, 37203, United States
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Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510, United States
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