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

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:

• 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.

Study Overview

• Status: Terminated
• Conditions: Melanoma; Non-Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Classical Hodgkin Lymphoma; Diffuse Large B-cell Lymphoma; Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: PF-08046032; Drug: Sasanlimab

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center- Montlake
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

1. 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
2. Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors
3. Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment
4. ECOG Performance Status score 0 or 1

EXCLUSION CRITERIA:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08046032 Monotherapy Dose Escalation; PF-08046032 will be given as an intravenous (IV) infusion.	Drug: PF-08046032; PF-08046032 will be administered intravenously (IV) infusion.
Experimental: PF-08046032 + Sasanlimab Combination Safety Evaluation; PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.	Drug: PF-08046032; PF-08046032 will be administered intravenously (IV) infusion.; Drug: Sasanlimab; Sasanlimab will be administered as subcutaneous (SC) injection.
Experimental: PF-08046032 + Sasanlimab Combination Expansion Cohort; PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.	Drug: PF-08046032; PF-08046032 will be administered intravenously (IV) infusion.; Drug: Sasanlimab; Sasanlimab will be administered as subcutaneous (SC) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days)
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)	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
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	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
All Parts: Number of participants with clinically significant lab abnormalities	Lab abnormalities characterized by type, frequency, and severity (CTCAE v5)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
Duration of Response (DoR) in Participants with Solid Tumors	Based on investigator assessment for participants with a confirmed objective response (CR or PR) only.	Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years)
Progression-free survival (PFS) in Participants with Solid Tumors	Based on investigator assessment for tumor response/progression according to RECIST v1.1	Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years)
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	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)
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	Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years)
Duration of Response (DoR) in participants with lymphomas based on Lugano Criteria	Based on investigator assessment for participants with a confirmed objective response only.	Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years)
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	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)
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.	Time from first documented CR to the date of the first radiographic progression or death (Approximately 3 Years)
Part C only: Overall survival (OS)	OS is defined as time from first dose of study treatment to death due to any cause.	Baseline through date of death or study completion, whichever occurs first (up to approximately 3 Years)
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	Baseline through about 7 weeks after first dose
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).	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)
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).	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)
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)	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)
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)	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)
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)	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)
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	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Actual): April 23, 2026
• Study Completion (Actual): April 23, 2026

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Solid tumors; Lung cancer; Skin cancer; Metastatic Cancer; Malignancies; Advanced Malignancies; Hodgkin lymphoma; Advanced Cancers; Non-Hodgkin lymphoma; Blood Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Hematologic Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Skin Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Lymphoma, B-Cell; Lymphoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Carcinoma, Squamous Cell; Lymphoma, T-Cell; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Lung Neoplasms; Hematologic Neoplasms; Lymphoma, Large B-Cell, Diffuse; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Lymphoma, Non-Hodgkin; Melanoma; Hodgkin Disease; Lymphoma, T-Cell, Peripheral; Skin Neoplasms
• Other Study ID Numbers: C5911001; 2024-517756-35-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes