NCT05208762

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 714 (estimated)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Squamous Cell Carcinoma of the Head and Neck
• Esophageal Squamous Cell Carcinoma
• Triple Negative Breast Neoplasms
• Gastric Cancer
• Endometrial Cancer
• Pancreatic Adenocarcinoma
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	PF-08046054	Given into the vein (IV; intravenously)
DRUG	pembrolizumab	200 mg once every 3 weeks given into the vein (IV; intravenously)

Timeline

• Start date: 2022-10-25
• Primary completion: 2028-01-05
• Completion: 2029-01-04
• First posted: 2022-01-26
• Last updated: 2026-02-23

Locations

61 sites across 11 countries: United States, Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study