Recruiting
Phase 1

PF-08046054

Sponsor:

Seagen, a wholly owned subsidiary of Pfizer

Code:

NCT05208762

Conditions

Carcinoma, Non-Small-Cell Lung

Squamous Cell Carcinoma of the Head and Neck

Esophageal Squamous Cell Carcinoma

Triple Negative Breast Neoplasms

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08046054

pembrolizumab

Study Details

Brief 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

Study ID

NCT05208762

Start date

Oct 25, 2022

Status verified date

Jul, 2026

Completion date

Jan 4, 2029

Anticipated

Primary completion date

Jan 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Parts A and B:

  • Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types

  • Non-small cell lung cancer (NSCLC)
  • Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
  • Esophageal squamous cell carcinoma (SCC)
  • Triple negative breast cancer (TNBC)
  • Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
  • Participants must have PD-L1 expression based on historical testing
  • Part C:

  • Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types

  • HNSCC

  • Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
  • NSCLC

  • Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
  • Esophageal SCC
  • Pancreatic cancer
  • Hepatocellular carcinoma
  • TNBC
  • Gastric cancer
  • Endometrial cancer
  • 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
  • Part D and Part E:

  • Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
  • Participants must have PD-L1 expression based on historical testing
  • Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
  • Participants with HNSCC; PD--L1 expression ≥1 by CPS
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

  • History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
  • Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:

  • Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
  • Have no new or enlarging brain metastases
  • And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
  • Lepto-meningeal disease
  • Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
  • Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
  • Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Study Design

Enrollment

714 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-08046054 Monotherapy

PF-08046054 monotherapy

experimental: PF-08046054 Combination Therapy

PF-08046054 + pembrolizumab

Interventions

PF-08046054

Given into the vein (IV; intravenously)

pembrolizumab

200 mg once every 3 weeks given into the vein (IV; intravenously)

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Through approximately 90 days after last study treatment; up to 3 years ]
  • Number of participants with laboratory abnormalities [ Time Frame: Through approximately 90 days after last study treatment; up to 3 years ]
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]
  • Number of participants with DLTs by dose level [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]

Central Contacts and Locations

Central contacts

Seagen Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham, IDS Pharmacy

Recruiting

Birmingham, Alabama, United States, 35249

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

UC Irvine Health - Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Karmanos Cancer Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

University of Texas Southwestern Medical Center - Simmons Cancer Center

Recruiting

Dallas, Texas, United States, 75235

UT Southwestern Medical Center - Redbird

Recruiting

Dallas, Texas, United States, 75237

Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital

Recruiting

Dallas, Texas, United States, 75390

University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital

Recruiting

Dallas, Texas, United States, 75390

University Of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

UT Southwestern - Simmons Cancer Center - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

Recruiting

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

UT Southwestern - Simmons Cancer Center - Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

NEXT Virginia, LLC

Recruiting

San Antonio, Texas, United States, 78229

South Texas Accelerated Research Therapeutics, LLC

Recruiting

San Antonio, Texas, United States, 78229

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

University Health Network, Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Non-small cell lung cancer
  • NSCLC
  • Head and neck squamous cell carcinoma
  • HNSCC
  • Triple Negative Breast Cancer
  • TNBC
  • Gastric cancer
  • Seattle Genetics
  • HCC
  • PDAC
  • Esophageal
  • Pfizer
  • Endometrial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Seagen, a wholly owned subsidiary of Pfizer on 2026-07-22.