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OncoMatch/Clinical Trials/NCT05208762

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

Is NCT05208762 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PF-08046054 and pembrolizumab for carcinoma, non-small-cell lung.

Phase 1RecruitingSeagen, a wholly owned subsidiary of PfizerNCT05208762Data as of May 2026

Treatment: PF-08046054 · pembrolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Esophageal Carcinoma

Triple-Negative Breast Cancer

Breast Carcinoma

Gastric Cancer

Endometrial Cancer

Pancreatic Cancer

Hepatocellular Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) expression (historical PD-L1 testing required)

Participants must have PD-L1 expression based on historical testing

Required: PD-L1 (CD274) expression ≥1 or <1 by CPS or TPS (expression ≥1 or <1 by CPS or TPS)

Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing

Required: PD-L1 (CD274) expression ≥1% by TPS (expression ≥1% by TPS)

Participants with NSCLC; PD-L1 expression ≥ 1% by TPS

Required: PD-L1 (CD274) expression ≥1 by CPS (expression ≥1 by CPS)

Participants with HNSCC; PD--L1 expression ≥1 by CPS

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-L1 therapy

Exception: allowed if prior anti-PD-L1 agent was received ≥5 half-lives before study entry

Prior treatment with an anti-PD-L1 agent within less than 5 half-lives

Cannot have received: antibody-drug conjugate (MMAE-containing agent)

Previous receipt of an monomethylauristatin E (MMAE)-containing agent

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham · Birmingham, Alabama
  • University of Alabama at Birmingham, IDS Pharmacy · Birmingham, Alabama
  • University of Alabama at Birmingham · Birmingham, Alabama
  • University of Alabama at Birmingham · Birmingham, Alabama
  • Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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