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Peripheral T Cell LymphomaPhase 1NCT06870487

A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers

A Phase 1 study testing PF-08046032 and Sasanlimab in people with Peripheral T Cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Pfizer at 4 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 effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046032 and Sasanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesin 2 countries
Study dates
8 May 2025to 23 Apr 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

Who may be able to join

  • Histological or cytological diagnosis of metastatic or unresectable malignancy:
  • Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies
  • Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available
  • Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy
  • Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor
  • Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors
  • Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment
  • ECOG Performance Status score 0 or 1

Who cannot join

  • Ongoing peripheral neuropathy
  • History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy
  • Known or suspected active autoimmune disease

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Center.

    Seattle, Washington, 98109

  • University of Washington Medical Center- Montlake

    Seattle, Washington, 98195

Other trials in United States

Spain1 site

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

Other trials in Spain

About this study

Official title: An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants With Advanced Malignancies

The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body).

The study has three parts:

Read more
  • Part A will test PF-08046032 alone at increasing dose levels in participants with certain lymphomas (cancer that begins in cells of the immune system) and in participants with certain solid tumors whose disease has worsened on or after standard treatments.
  • Part B will test PF-08046032 (at selected doses) and sasanlimab in participants with certain solid tumors, including those whose disease has worsened on or after standard treatments as well as participants before receiving standard treatments.
  • Part C will further test the combination of PF-08046032 and sasanlimab in participants with specific types of solid tumors based on the results from Part A and Part B of the study.

All participants will receive the study drug PF-08046032. Only participants in Part B and Part C of the study will also receive sasanlimab. PF-08046032 will be given as an intravenous (IV) infusion, which means it will be injected directly into a vein. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.

Being tested
PF-08046032, Sasanlimab
Keywords
Solid tumors, Advanced Malignancies, Malignancies, Lung cancer, Skin cancer, Non-Hodgkin lymphoma, Hodgkin lymphoma, Advanced Cancers, Head and Neck Cancer, Metastatic Cancer, Blood Cancer
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse, Squamous Cell Carcinoma of Head and Neck, Melanoma, Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms, Skin Neoplasms

What participants receive

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

  • PF-08046032Drug

    PF-08046032 will be administered intravenously (IV) infusion.

  • SasanlimabDrug

    Sasanlimab will be administered as subcutaneous (SC) injection.

Study groups in NCT06870487
Study groupRoleWhat they receive
PF-08046032 Monotherapy Dose EscalationExperimentalPF-08046032 will be given as an intravenous (IV) infusion.
Receives: Drug: PF-08046032
PF-08046032 + Sasanlimab Combination Safety EvaluationExperimentalPF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.
Receives: Drug: PF-08046032; Drug: Sasanlimab
PF-08046032 + Sasanlimab Combination Expansion CohortExperimentalPF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.
Receives: Drug: PF-08046032; Drug: Sasanlimab

What is being measured

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

  1. Part A and Part B: Number of participants with dose limiting toxicities (DLTs) in dose escalation

    DLT (any of the prespecified AEs that are attributable to study treatment(s), excluding toxicities clearly due to underlying disease or extraneous causes) rate estimated based on data from DLT-evaluable participants during the DLT evaluation period

    Measured: Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days)

  2. All Parts: Number of participants with adverse events (AEs)

    AEs as characterized by type, frequency, severity (CTCAE v5), seriousness, and relationship to study drug(s)

    Measured: From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab

  3. All Parts: Frequency of dose modifications due to AEs

    Dose modifications such as dose delay, treatment interruptions, dose reducations, and treatment discontinuations due to AEs

    Measured: From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab

  4. All Parts: Number of participants with clinically significant lab abnormalities

    Lab abnormalities characterized by type, frequency, and severity (CTCAE v5)

    Measured: From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab

Secondary outcomes (16)

  1. Objective Response Rate (ORR) in Participants with Solid Tumors

    Based on investigator assessment, and defined as the proportion of participants who achieved best overall response of CR or PR according to RECIST 1.1

    Measured: Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years)

  2. Duration of Response (DoR) in Participants with Solid Tumors

    Based on investigator assessment for participants with a confirmed objective response (CR or PR) only.

    Measured: Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years)

  3. Progression-free survival (PFS) in Participants with Solid Tumors

    Based on investigator assessment for tumor response/progression according to RECIST v1.1

    Measured: Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years)

  4. Objective Response Rate (ORR) in participants with lymphomas based on Lugano Criteria

    Based on investigator assessment, and defined as the proportion of participants who achieved best overall response according to Lugano Criteria

    Measured: Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years)

  5. Progression-free survival (PFS) in participants with lymphomas based on Lugano Criteria

    Based on investigator assessment for tumor response/progression according to Lugano Response Classification Criteria

    Measured: Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years)

  6. Duration of Response (DoR) in participants with lymphomas based on Lugano Criteria

    Based on investigator assessment for participants with a confirmed objective response only.

    Measured: Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years)

  7. Complete Response Rate (CRR) in participants with lymphomas

    Based on investigator assessment, and defined as the proportion of participants who achieved best overall response of Complete Response (CR) according to Lugano Criteria

    Measured: Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years)

  8. Duration of Complete Response (DCR) in participants with lymphomas

    Based on investigator assessment for participants with lymphoma with a confirmed objective response per Lugano Criteria only.

    Measured: Time from first documented CR to the date of the first radiographic progression or death (Approximately 3 Years)

  9. Part C only: Overall survival (OS)

    OS is defined as time from first dose of study treatment to death due to any cause.

    Measured: Baseline through date of death or study completion, whichever occurs first (up to approximately 3 Years)

  10. Part A2 only: Change from baseline of the number of CD25+ cells in tumor in response to PF-08046032 treatment

    Change is evaluated from paired biopsies

    Measured: Baseline through about 7 weeks after first dose

  11. Pharmacokinetics (PK): Serum Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

    AUClast of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C).

    Measured: Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days)

  12. PK: Maximum Observed Serum Concentration (Cmax)

    Cmax of of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C).

    Measured: Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days)

  13. PK: Half-life (t1/2)

    Half life of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C)

    Measured: Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days)

  14. PK: Minimum observed serum concentration (Ctrough)

    Ctrough of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C)

    Measured: Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days)

  15. PK: Time to Reach Maximum Observed Serum Concentration (Tmax)

    Tmax of PF-08046032 as a monotherapy (Part A) and in combination with sasanlimab (Part B and Part C)

    Measured: Cycle 1 and Cycle 2, and pre-and post-dosing on Day 1 of Cycle 3, 4, 6, 8, and every 4th cycle thereafter; and within approximately 30 days after last dose of study drug (each cycle is 28 days)

  16. Incidence of Anti-Drug Antibody (ADA): Immunogenicity of PF-08046032 as a single agent (Part A) and in combination with sasanlimab (Part B and Part C)

    Immunogenicity of PF-08046032 and in combination with sasanlimab

    Measured: Pre-dose on Day 1 of Cycles 1-4, then cycle 6, 8, and every 4th cycle thereafter, and within approximately 30 days after last dose of study drug (each cycle is 28 days)

Timeline

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

  1. First posted11 Mar 2025
  2. Study start8 May 2025
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06870487
Sponsor's protocol ID
C5911001
Other IDs
2024-517756-35-00
Status last verified
May 2026
First submitted
24 Feb 2025
Last updated
8 May 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-08046032 and Sasanlimab in people with Peripheral T Cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Pfizer at 4 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?

The sponsor lists 8 inclusion and 3 exclusion criteria. 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Spain. 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?

Part A and Part B: Number of participants with dose limiting toxicities (DLTs) in dose escalation (time frame: Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days)). The study lists 4 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 NCT06870487.

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 8 May 2026.

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