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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 25, 2022

Status verified

Apr 2026

Primary completion

Jan 5, 2028

Completion

Jan 4, 2029

Study Design

Enrollment

714 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: PF-08046054 Monotherapy
  PF-08046054 monotherapy
• Experimental: PF-08046054 Combination Therapy
  PF-08046054 + pembrolizumab

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Through approximately 90 days after last study treatment; up to 3 years ]

Central Contacts

• Seagen Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (25)

Find similar trials in Birmingham, AL

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