NCT06974734

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Carcinoma, Non Small Cell Lung
• Carcinoma, Pancreatic Ductal
• Malignant Melanoma
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Interventions

Type	Name	Description
DRUG	PF-08046037	Given into the vein (IV; intravenous)
DRUG	sasanlimab	Given under the skin (SQ; subcutaneous)

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-03-31
• Completion: 2026-04-30
• First posted: 2025-05-16
• Last updated: 2026-04-07

Locations

15 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study