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Carcinoma, Non Small Cell LungPhase 1NCT06974734

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

A Phase 1 study testing PF-08046037 and sasanlimab in people with Carcinoma, Non Small Cell Lung and Carcinoma, Pancreatic Ductal, run by Pfizer at 15 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046037 and sasanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
15 sitesin 2 countries
Study dates
6 May 2025to 31 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  1. 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
  1. 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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States14 sites

  • Presbyterian/ St. Lukes Medical Center

    Denver, Colorado, 80218

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • START Midwest

    Grand Rapids, Michigan, 49546

  • Community Health Network, Inc

    Indianapolis, Indiana, 46219

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Smilow Cancer Hospital - Yale New Haven Health

    New Haven, Connecticut, 06510

  • Yale - New Haven Hospital - Yale Cancer Center

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511

  • Smilow Cancer Hospital - Trumbull

    Trumbull, Connecticut, 06611

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED 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:

Read more
  • 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.

Being tested
PF-08046037, sasanlimab
Keywords
Advanced solid tumors, NSCLC, PDAC, HNSCC, ISAC, ADC, PD-L1 inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal, Melanoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046037Drug

    Also called SGN-PDL1iT

    Given into the vein (IV; intravenous)

  • sasanlimabDrug

    Also called PF-06801591

    Given under the skin (SQ; subcutaneous)

Study groups in NCT06974734
Study groupRoleWhat they receive
Part 1aExperimentalPF-08046037 monotherapy dose escalation
Receives: Drug: PF-08046037
Part 2aExperimentalPF-08046037 monotherapy dose optimization
Receives: Drug: PF-08046037
Part 3aExperimentalPF-08046037 monotherapy dose expansion
Receives: Drug: PF-08046037
Part 1bExperimentalPF-08046037 +sasanlimab dose escalation
Receives: Drug: PF-08046037; Drug: sasanlimab
Part 2bExperimentalPF-08046037 + sasanlimab dose optimization
Receives: Drug: PF-08046037; Drug: sasanlimab
Part 3bExperimentalPF-08046037 + sasanlimab dose expansion
Receives: Drug: PF-08046037; Drug: sasanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  2. Number of participants with laboratory abnormalities

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  3. Number of dose modifications due to AEs

    Measured: Through end of treatment up to approximately 2 years

  4. Number of participants with dose-limiting toxicities (DLTs)

    Measured: Up to 21 days

  5. Number of participants with DLTs by dose level

    Measured: Up to 21 days

Secondary outcomes (12)

  1. Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  2. PK parameter - Maximum concentration (Cmax)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  3. PK parameter - Time to maximum concentration (Tmax)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  4. PK parameter - t1/2

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  5. PK parameter - Trough concentration (Ctrough)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  6. Number of participants with antidrug antibodies (ADAs)

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  7. Objective response rate (ORR)

    The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.

    Measured: Through end of study and up to approximately 2 years

  8. Best overall response

    The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.

    Measured: Through end of study and up to approximately 2 years

  9. Duration of response (DOR)

    DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause

    Measured: Through end of study and up to approximately 2 years

  10. Progression-free survival (PFS)

    PFS is defined as the time from start of PF-08046037 to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first

    Measured: Through end of study and up to approximately 2 years

  11. Overall survival (OS)

    OS is defined as the time from start of PF-08046037 to date of death due to any cause

    Measured: Through end of study and up to approximately 2 years

  12. Percent change of cells within tumors based on multiplex immunofluorescence

    This measure will assess the number of immune cells, PD-1, PD-L1, and TLR7 expression within the tumor microenvironment.

    Measured: Through end of study and up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start6 May 2025
  3. Primary completion20 Mar 2026
  4. Study completion31 Mar 2026

Why it stopped: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation and expansion
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974734
Sponsor's protocol ID
C5941001
Other IDs
2025-521499-69-00, 2025
Status last verified
Apr 2026
First submitted
22 Apr 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046037 and sasanlimab in people with Carcinoma, Non Small Cell Lung and Carcinoma, Pancreatic Ductal, run by Pfizer at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Through 30-37 days after the last study treatment, up to approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06974734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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