Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05208762

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

Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-04-20

714

Participants Needed

61

Research Sites

323 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 61 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States, 35249

Actively Recruiting

3

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Actively Recruiting

4

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

5

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States, 92612

Actively Recruiting

6

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

Actively Recruiting

7

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

8

University of California, Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

9

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

10

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

11

Karmanos Cancer Institute

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

12

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

13

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, United States, 75235

Actively Recruiting

14

UT Southwestern Medical Center - Redbird

Dallas, Texas, United States, 75237

Actively Recruiting

15

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

Dallas, Texas, United States, 75390

Actively Recruiting

16

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

Dallas, Texas, United States, 75390

Actively Recruiting

17

University Of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

18

UT Southwestern - Simmons Cancer Center - Fort Worth

Fort Worth, Texas, United States, 76104

Actively Recruiting

19

The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

Houston, Texas, United States, 77030

Actively Recruiting

20

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

21

UT Southwestern - Simmons Cancer Center - Richardson/Plano

Richardson, Texas, United States, 75080

Actively Recruiting

22

NEXT Virginia, LLC

San Antonio, Texas, United States, 78229

Actively Recruiting

23

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

Actively Recruiting

24

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

25

NEXT Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

26

Institut Jules Bordet

Anderlecht, Belgium, 1070

Actively Recruiting

27

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

28

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

29

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

30

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

31

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

32

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, China, 101100

Actively Recruiting

33

Shanghai East Hospital

Shanghai, Shanghai Municipality, China, 200123

Actively Recruiting

34

Hôpital Saint André - CHU Bordeaux

Bordeaux, France, 33075

Actively Recruiting

35

Clinique Ambroise Pare

Neuilly-sur-Seine, France, 92200

Actively Recruiting

36

lnstitut Curie Pharmacy

Paris, France, 75005

Actively Recruiting

37

Institut Curie

Paris, France, 75248

Actively Recruiting

38

Gustave Roussy Institute - Service pharmacie

Villejuif, France, 94805

Actively Recruiting

39

Charite Comprehensive Cancer Center

Berlin, Germany, 10117

Actively Recruiting

40

Charite Universitatsmedizin Berlin

Berlin, Germany, 12200

Actively Recruiting

41

Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum

Berlin, Germany, 13353

Actively Recruiting

42

Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

Milan, Milan, Italy, 20141

Actively Recruiting

43

Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi

Verona, Other, Italy, 37134

Actively Recruiting

44

Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi

Verona, Veneto, Italy, 37134

Actively Recruiting

45

UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, Italy, 40138

Actively Recruiting

46

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

47

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan, 411-8777

Actively Recruiting

48

The Netherlands Cancer Institute

Amsterdam, Netherlands, 1066 CX

Actively Recruiting

49

CETIR Viladomat

Barcelona, Other, Spain, 08029

Actively Recruiting

50

Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)

Barcelona, Other, Spain, 08908

Actively Recruiting

51

Hospital Quiron Salud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

52

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

53

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

54

START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

55

Diagnostic Centre

London, Others, United Kingdom, W1G 7AF

Actively Recruiting

56

The Harley Street Clinic (THSC)

London, Other, United Kingdom, W1G 8BJ

Actively Recruiting

57

Pharmacy: Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

58

Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

59

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

60

Sarah Cannon Research Institute

London, United Kingdom, W1G 6AD

Actively Recruiting

61

Radiology

London, United Kingdom, W1G 8PP

Actively Recruiting

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Research Team

S

Seagen Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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