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

NCT06870487 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C59110012024-517756-35-00
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 4

Brief 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. 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.

Conditions

Peripheral T Cell Lymphoma; Diffuse Large B-cell Lymphoma; Classical Hodgkin Lymphoma; Head and Neck Squamous Cell Carcinoma; Melanoma; Non-Small Cell Lung Cancer

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Objective Response Rate (ORR) in Participants with Solid Tumors

  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

  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

  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

  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

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

Study Arms (3)

PF-08046032 Monotherapy Dose Escalation

EXPERIMENTAL

PF-08046032 will be given as an intravenous (IV) infusion.

Drug: PF-08046032

PF-08046032 + Sasanlimab Combination Safety Evaluation

EXPERIMENTAL

PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.

Drug: PF-08046032; Drug: Sasanlimab

PF-08046032 + Sasanlimab Combination Expansion Cohort

EXPERIMENTAL

PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.

Drug: PF-08046032; Drug: Sasanlimab

Interventions

PF-08046032 DRUG

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

PF-08046032 + Sasanlimab Combination Expansion Cohort; PF-08046032 + Sasanlimab Combination Safety Evaluation; PF-08046032 Monotherapy Dose Escalation

Sasanlimab DRUG

Sasanlimab will be administered as subcutaneous (SC) injection.

PF-08046032 + Sasanlimab Combination Expansion Cohort; PF-08046032 + Sasanlimab Combination Safety Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Fred Hutchinson Cancer Center.

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center- Montlake

Seattle, Washington, 98195, United States

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Links

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

MeSH Terms

Conditions

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; Lymphoma, Non-Hodgkin; Hodgkin Disease; Head and Neck Neoplasms; Neoplasm Metastasis; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: May 8, 2025
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); ES (1)