NCT06870487

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	PF-08046032	PF-08046032 will be administered intravenously (IV) infusion.
DRUG	Sasanlimab	Sasanlimab will be administered as subcutaneous (SC) injection.

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-04-26
• Completion: 2026-04-26
• First posted: 2025-03-11
• Last updated: 2026-04-01

Locations

4 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study