RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-25
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05208762

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parts A and B:
  2. * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
  3. * Non-small cell lung cancer (NSCLC)
  4. * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
  5. * Esophageal squamous cell carcinoma (SCC)
  6. * Triple negative breast cancer (TNBC)
  7. * 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
  8. * Participants must have PD-L1 expression based on historical testing
  9. * Part C:
  10. * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
  11. * HNSCC
  12. * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
  13. * NSCLC
  14. * 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.
  15. * Esophageal SCC
  16. * Ovarian cancer
  17. * Melanoma
  18. * TNBC
  19. * Gastric cancer
  20. * 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
  21. * Part D and Part E:
  22. * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
  23. * Participants must have PD-L1 expression based on historical testing
  24. * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
  25. * Participants with HNSCC; PD--L1 expression ≥1 by CPS
  26. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  27. * Measurable disease per RECIST v1.1 at baseline
  1. * History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
  2. * Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:
  3. * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
  4. * Have no new or enlarging brain metastases
  5. * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
  6. * Lepto-meningeal disease
  7. * 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.
  8. * Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
  9. * Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

Contacts and Locations

Study Contact

Seagen Trial Information Support
CONTACT
866-333-7436
clinicaltrials@seagen.com

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Seagen Inc.

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, 92868
United States
University of California Davis
Sacramento, California, 95817
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City, Utah, 84119
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Seagen Inc.

  • Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-25
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-10-25
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Non-small cell lung cancer
  • NSCLC
  • Head and neck squamous cell carcinoma
  • HNSCC
  • Ovarian cancer
  • Triple Negative Breast Cancer
  • TNBC
  • Gastric cancer
  • Seattle Genetics

Additional Relevant MeSH Terms

  • 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