A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
NCT05208762 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 714
Last updated 2026-04-20
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
- DRUG
-
PF-08046054
Given into the vein (IV; intravenously)
- DRUG
-
200 mg once every 3 weeks given into the vein (IV; intravenously)
Sponsors & Collaborators
-
Seagen, a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-25
- Primary Completion
- 2028-01-05
- Completion
- 2029-01-04
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- China
- France
- Germany
- Italy
- Japan
- Netherlands
- Spain
- United Kingdom
Study Locations
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