Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04389632

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-05-11

1006

Participants Needed

159

Research Sites

458 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.

CONDITIONS

Official Title

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a confirmed metastatic or unresectable solid tumor of one of these types: non-small cell lung cancer, head and neck squamous cell cancer, advanced HER2-negative breast cancer, esophageal squamous cell carcinoma, esophageal or gastro-esophageal junction adenocarcinoma, cutaneous squamous cell cancer, exocrine pancreatic adenocarcinoma, bladder cancer, cervical cancer, gastric cancer, or high grade serous ovarian cancer
  • Part A: Disease must be relapsed, refractory, or intolerant to standard therapies without other options
  • Part B: Must have relapsed or refractory disease, received platinum-based therapy and PD-1/PD-(L)1 inhibitor if available
  • Part C: Eligible for pembrolizumab alone or with cisplatin or carboplatin; must be treatment-naïve for advanced or metastatic therapy
  • Part D: Treatment-naïve for advanced or metastatic systemic therapy
  • Participants in Parts B and D must have accessible tumor for biopsy and agree to biopsy; archival biopsy within 90 days allowed
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline
Not Eligible

You will not qualify if you...

  • History of another cancer within 3 years or residual disease from prior malignancy, except low-risk cancers
  • Active central nervous system metastases, unless stable and off corticosteroids for 7 days; small untreated asymptomatic CNS metastases allowed in Part D
  • Carcinomatous meningitis
  • Previous treatment with MMAE-containing agents or integrin beta-6 targeting agents
  • Pre-existing neuropathy Grade 1 or higher for cisplatin/carboplatin groups; Grade 2 or higher for other groups
  • Uncontrolled serious infections within 2 weeks before starting study drug
  • Severe lung disease (Grade 3 or higher) unrelated to cancer
  • Prior immune therapy discontinued due to severe immune-related side effects (Parts C and D)
  • History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out
  • Lung function with diffusing capacity (DLCO) less than 50% predicted
  • Investigator site staff and immediate family members involved in the study conduct or sponsorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 159 locations

1

Alaska Oncology and Hematology

Anchorage, Alaska, United States, 99508

Actively Recruiting

2

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

3

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

Actively Recruiting

4

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

Actively Recruiting

5

Providence Medical Foundation

Anaheim, California, United States, 92805

Actively Recruiting

6

Providence Medical Foundation

Fullerton, California, United States, 92835

Actively Recruiting

7

Providence St. Jude Medical Center Virginia K Crosson and Infusion Center

Fullerton, California, United States, 92835

Actively Recruiting

8

Cancer and Blood Research Center, LLC

Los Alamitos, California, United States, 90720

Not Yet Recruiting

9

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States, 90720

Not Yet Recruiting

10

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

11

The Regents of the University of California

Los Angeles, California, United States, 90095

Actively Recruiting

12

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, United States, 90095

Actively Recruiting

13

UCLA Department of Medicine - Hematology & Oncology

Santa Monica, California, United States, 90404

Actively Recruiting

14

Cancer AND Blood Specialty Clinic

Torrance, California, United States, 90505

Not Yet Recruiting

15

American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology

Fort Myers, Florida, United States, 33913

Actively Recruiting

16

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, United States, 33916

Actively Recruiting

17

Memorial Cancer Institute

Hollywood, Florida, United States, 33021

Actively Recruiting

18

Memorial Healthcare System

Hollywood, Florida, United States, 33021

Actively Recruiting

19

Florida Cancer Specialists

Orlando, Florida, United States, 32827

Actively Recruiting

20

Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida, United States, 33028

Actively Recruiting

21

Memorial Hospital West

Pembroke Pines, Florida, United States, 33028

Actively Recruiting

22

Ingalls Family Care Center

Calumet City, Illinois, United States, 60409

Actively Recruiting

23

UChicago Medicine - River East

Chicago, Illinois, United States, 60611

Actively Recruiting

24

The University Of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

25

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

26

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, United States, 60422

Actively Recruiting

27

UChicago Medicine Ingalls Memorial

Harvey, Illinois, United States, 60426

Actively Recruiting

28

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States, 60451

Actively Recruiting

29

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, United States, 60462

Actively Recruiting

30

Southern Illinois University - Simmons Cancer Institute

Springfield, Illinois, United States, 62702

Actively Recruiting

31

Springfield Clinic Radiology - 800 Building

Springfield, Illinois, United States, 62702

Actively Recruiting

32

Springfield Clinic Urgent Care Plus

Springfield, Illinois, United States, 62702

Actively Recruiting

33

Springfield Clinic

Springfield, Illinois, United States, 62702

Actively Recruiting

34

Springfield Clinic Main Campus

Springfield, Illinois, United States, 62703

Actively Recruiting

35

Springfield Clinic Radiology - Main Campus

Springfield, Illinois, United States, 62703

Actively Recruiting

36

Springfield Memorial Hospital

Springfield, Illinois, United States, 62781

Actively Recruiting

37

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, United States, 60477

Actively Recruiting

38

UChicago Medicine - Northwest Indiana

Crown Point, Indiana, United States, 46307

Actively Recruiting

39

Fort Wayne Medical Oncology and Hematology, Inc

Fort Wayne, Indiana, United States, 46804

Actively Recruiting

40

Community Health Network, Inc

Indianapolis, Indiana, United States, 46219

Actively Recruiting

41

Community Health Network, Inc.

Indianapolis, Indiana, United States, 46227

Actively Recruiting

42

Community Health Network Investigational Drug Services

Indianapolis, Indiana, United States, 46250

Actively Recruiting

43

Community Health Network, Inc.

Indianapolis, Indiana, United States, 46250

Actively Recruiting

44

The University of Kansas Cancer Center, Investigational Drug Services

Fairway, Kansas, United States, 66205

Actively Recruiting

45

The University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

Actively Recruiting

46

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

47

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States, 66160

Actively Recruiting

48

University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, United States, 66160

Actively Recruiting

49

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States, 66160

Actively Recruiting

50

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, United States, 66211

Actively Recruiting

51

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States, 66205

Actively Recruiting

52

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

53

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

54

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

55

Beth Israel Deaconess Medical Center,East Campus Research Pharmacy

Boston, Massachusetts, United States, 02215

Actively Recruiting

56

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

57

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

58

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, United States, 02467

Actively Recruiting

59

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

60

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

61

Allina Health Cancer Institute

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

62

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Actively Recruiting

63

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Babylon, New York, United States, 11702

Actively Recruiting

64

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Brooklyn, New York, United States, 11210

Actively Recruiting

65

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

New Hyde Park, New York, United States, 11042

Actively Recruiting

66

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

New York, New York, United States, 10028

Actively Recruiting

67

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

68

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Patchogue, New York, United States, 11772

Actively Recruiting

69

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States, 11776

Actively Recruiting

70

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Riverhead, New York, United States, 11901

Actively Recruiting

71

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Shirley, New York, United States, 11967

Actively Recruiting

72

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

The Bronx, New York, United States, 10469

Actively Recruiting

73

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Active, Not Recruiting

74

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

75

Stephenson Cancer Center (chemo location)

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

76

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

77

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Actively Recruiting

78

Providence Oncology and Hematology Care Clinic - Westside

Portland, Oregon, United States, 97225

Actively Recruiting

79

Providence St. Vincent Medical Center- Investigational Drug Services

Portland, Oregon, United States, 97225

Actively Recruiting

80

Providence St. Vincent Medical Center

Portland, Oregon, United States, 97225

Actively Recruiting

81

Sanford Cancer Center

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

82

Sanford USD Medical Center

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

83

US Oncology Research LLC

Nashville, Tennessee, United States, 37203

Actively Recruiting

84

Oncology Consultants, PA

Houston, Texas, United States, 77024

Actively Recruiting

85

Oncology Consultants, PA.

Houston, Texas, United States, 77030

Actively Recruiting

86

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

87

US Oncology Investigational Product Center (IPC)

Irving, Texas, United States, 75063

Actively Recruiting

88

Houston Medical Imaging

Pearland, Texas, United States, 77581

Not Yet Recruiting

89

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

Active, Not Recruiting

90

UT Health East Texas HOPE Cancer Center

Tyler, Texas, United States, 75701

Actively Recruiting

91

UT Health East Texas Hope Cancer Center

Tyler, Texas, United States, 75708

Actively Recruiting

92

Tranquil Clinical Research

Webster, Texas, United States, 77598

Not Yet Recruiting

93

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

94

Northwest Medical Specialities. PLLC

Bonney Lake, Washington, United States, 98391

Not Yet Recruiting

95

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, United States, 98026

Actively Recruiting

96

Swedish Cancer Institute Edmonds Campus

Edmonds, Washington, United States, 98026

Actively Recruiting

97

Northwest Medical Specialities.PLLC

Federal Way, Washington, United States, 98003

Not Yet Recruiting

98

Northwest Medical Specialities. PLLC

Gig Harbor, Washington, United States, 98332

Not Yet Recruiting

99

American Oncology Network Vista Oncology Division-West office

Olympia, Washington, United States, 98502

Actively Recruiting

100

American Oncology Network Vista Oncology Division-East office

Olympia, Washington, United States, 98506

Actively Recruiting

101

Northwest Medical Specialties, PPLC

Puyallup, Washington, United States, 98373

Not Yet Recruiting

102

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Actively Recruiting

103

Swedish Medical Center

Seattle, Washington, United States, 98122

Actively Recruiting

104

Exigent Research, LLC

Tacoma, Washington, United States, 98405

Actively Recruiting

105

Northwest Medical Specialities, PLLC

Tacoma, Washington, United States, 98405

Not Yet Recruiting

106

Center Hospitalier Universitaire d' Angers

Angers, France, 49100

Active, Not Recruiting

107

Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

Nice, France, 06189

Actively Recruiting

108

Centre Hospitalier Universitaire de Poitiers

Poitiers, France, 86021

Actively Recruiting

109

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France, 54519

Actively Recruiting

110

Institut Gustave Roussy Department de Pharmacie Clinique(-1)

Villejuif, France, 94805.

Actively Recruiting

111

lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)

Villejuif, France, 94805.

Actively Recruiting

112

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea, 10408

Actively Recruiting

113

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea, 28644

Actively Recruiting

114

Severance Hospital Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

115

Samsung Medical Center

Seoul, South Korea, 06351

Not Yet Recruiting

116

The Catholic University of Korea

Seoul, South Korea, 06591

Actively Recruiting

117

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea, 07061

Actively Recruiting

118

Korea University Guro Hospital

Seoul, South Korea, 08308

Actively Recruiting

119

Farmacia Ensayos Hospital HM Universitario Sanchinarro

Madrid, Agrigento, Spain, 28050

Actively Recruiting

120

Elche General University Hospital

Elche, Alicante, Spain, 03203

Actively Recruiting

121

Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario Marqués

Santander, Cantabria, Spain, 39008

Actively Recruiting

122

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain, 39008

Actively Recruiting

123

Hospital HM Nou Delfos

Barcelona, Catalonia, Spain, 08023

Actively Recruiting

124

Fundación Privada Instituto de Investigación Oncológica de Vall Hebron

Barcelona, Other, Spain, 08035

Actively Recruiting

125

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, OTH, Spain, 08023

Actively Recruiting

126

Elche General University Hospital

Elche, Valencia, Spain, 03203

Actively Recruiting

127

Hospital General Universitario de Elche

Elche, Valencia, Spain, 03203

Actively Recruiting

128

Farmacia Ensayos clínicos, Unidad START Barcelona

Barcelona, Spain, 08023

Actively Recruiting

129

Hospital HM Nou Delfos - START Barcelona

Barcelona, Spain, 08023

Actively Recruiting

130

Hospital Quiron Salud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

131

NEXT Oncology - IOB Hospital Quironsalud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

132

Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer "la Caixa"

Barcelona, Spain, 08035

Actively Recruiting

133

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

134

Elche General University Hospital

Elche, Spain, 03203

Actively Recruiting

135

Hospital Universitario De Jerez

Jerez de la Frontera, Spain, 10407

Actively Recruiting

136

UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez

Jerez de la Frontera, Spain, 10407

Actively Recruiting

137

Hospital Universitario de Jerez

Jerez de la Frontera, Spain, 11407

Actively Recruiting

138

Fundación de Investigación Hm Hospitales, C.I.F. G-83643841

Madrid, Spain, 28015

Actively Recruiting

139

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

140

Servicio de Radiologia Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

141

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

142

Hospital Universitario 12 Octubre

Madrid, Spain, 28041

Actively Recruiting

143

Hospital HM Sanchinarro, START-Madrid-CIOCC

Madrid, Spain, 28050

Actively Recruiting

144

Quironsalud Malaga

Málaga, Spain, 129004

Actively Recruiting

145

Kantonsspital Graubunden

Chur, Switzerland, 7000

Actively Recruiting

146

University Hospital Lausanne CHUV

Lausanne, Switzerland, 1011

Actively Recruiting

147

CHUV - Service de pharmacie BH-04, Essais cliniques

Lausanne, Switzerland, CH-1011

Actively Recruiting

148

Kaohsiung Medical University Hospital

Kaohsiung City, R.o.c., Taiwan, 80756

Actively Recruiting

149

National Taiwan University Hospital

Taipei, Taiwan, 100, R.O.C

Not Yet Recruiting

150

Taipei Veterans General Hospital.

Taipei, Taiwan, 11217

Actively Recruiting

151

The Royal Marsden Hospital (Surrey)

Sutton, Queensland, United Kingdom, SM2 5PT

Actively Recruiting

152

Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

153

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

154

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

155

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

156

Sarah Cannon Research Institute

London, United Kingdom, W1G 6AD

Actively Recruiting

157

Diagnostic centre

London, United Kingdom, W1G 7AF

Actively Recruiting

158

The Harley Street Clinic

London, United Kingdom, W1G 8BJ

Actively Recruiting

159

Radiology

London, United Kingdom, W1G 8PP

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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A Study of Sigvotatug Vedotin in Advanced Solid Tumors | DecenTrialz