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

Description

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, Ovarian Neoplasms, Melanoma, Triple Negative Breast Neoplasms, Gastric Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294-3300

Orange

Chao Family Comprehensive Cancer Center University of California Irvine, Orange, California, United States, 92868

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Detroit

Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States, 48201

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States, 78229

West Valley City

South Texas Accelerated Research Therapeutics Mountain Region, West Valley City, Utah, United States, 84119

Fairfax

NEXT Oncology, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Ovarian cancer
  • * Melanoma
  • * TNBC
  • * Gastric 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Seagen Inc.,

Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

2027-12-31