Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06157892

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

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

172

Participants Needed

141

Research Sites

270 weeks

Total Duration

On this page

Sponsors

S

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

R

RemeGen Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

CONDITIONS

Official Title

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Measurable disease according to RECIST v1.1
  • ECOG Performance Status score of 0 or 1
  • Histologically or cytologically confirmed breast carcinoma or gastric/gastroesophageal junction adenocarcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • Experienced disease progression on or after standard therapies or intolerant of them
  • For HER2-low breast cancer: HER2-low status (IHC 1+ or IHC 2+/ISH-negative)
  • No more than 3 prior systemic chemotherapy regimens for locally advanced/metastatic breast cancer
  • For known BRCA mutation, prior PARP-inhibitor treatment if available and not contraindicated
  • Progression on or intolerance to certain therapies like T-DXd, sacituzumab govitecan, or topoisomerase I inhibitors
  • For hormone receptor positive tumors, intolerance or refractory to endocrine therapy with specific prior treatments
  • For HER2+ breast cancer: HER2+ status (IHC 3+ or IHC 2+/ISH+)
  • Prior trastuzumab, pertuzumab, and taxane if available for advanced disease
  • For HER2-low gastric cancer: HER2-low expression (IHC 1+ or IHC 2+/ISH-negative)
  • Prior systemic therapy with platinum, fluorouracil, or taxane for advanced gastric cancer
  • No prior HER2-directed therapy for HER2-low gastric cancer
  • For HER2+ gastric cancer: HER2+ status (IHC 3+ or IHC 2+/ISH+)
  • Prior trastuzumab plus fluoropyrimidine and platinum chemotherapy unless contraindicated
  • No more than 2 prior systemic chemotherapy regimens for advanced gastric cancer
Not Eligible

You will not qualify if you...

  • Known allergy to disitamab vedotin or tucatinib or their ingredients
  • Prior treatment with ADCs containing MMAE or prior tucatinib therapy
  • Active central nervous system or leptomeningeal metastases
  • Received systemic anticancer treatment including investigational agents within 4 weeks before study treatment
  • History of other invasive cancers within 3 years or evidence of residual disease from previous cancers
  • Unable to swallow oral medications or have gastrointestinal conditions preventing adequate absorption

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 141 locations

1

Banner-University Medical Center Tucson Campus

Tucson, Arizona, United States, 85704

Actively Recruiting

2

Banner-University Medical Center Tucson Campus

Tucson, Arizona, United States, 85719

Actively Recruiting

3

The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal

Tucson, Arizona, United States, 85719

Actively Recruiting

4

University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States, 85719

Actively Recruiting

5

The University of Arizona Cancer Center-Main

Tucson, Arizona, United States, 85724

Actively Recruiting

6

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

Actively Recruiting

7

UC Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

8

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, United States, 94158

Actively Recruiting

9

UCLA Department of Medicine - Hematology & Oncology

Santa Monica, California, United States, 90404

Actively Recruiting

10

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States, 90404

Actively Recruiting

11

Colorado West Healthcare System, dba Community Hospital

Grand Junction, Colorado, United States, 81505

Not Yet Recruiting

12

Colorado West Healthcare, dba Grand Valley Oncology

Grand Junction, Colorado, United States, 81505

Not Yet Recruiting

13

Danbury Hospital

Danbury, Connecticut, United States, 06810

Not Yet Recruiting

14

Praxair Cancer Center / Danbury Hospital

Danbury, Connecticut, United States, 06810

Actively Recruiting

15

The Whittingham Cancer Center / Norwalk Hospital

Norwalk, Connecticut, United States, 06856

Not Yet Recruiting

16

Georgetown University Medical Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

17

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

18

Moffitt Cancer Center - International Plaza

Tampa, Florida, United States, 33607

Actively Recruiting

19

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Actively Recruiting

20

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States, 33612

Actively Recruiting

21

Moffitt McKinley Hospital

Tampa, Florida, United States, 33612

Actively Recruiting

22

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States, 33544

Actively Recruiting

23

Georgia Cancer Specialists - Athens

Athens, Georgia, United States, 30606

Actively Recruiting

24

Georgia Cancer Specialists - Annex

Atlanta, Georgia, United States, 30341

Actively Recruiting

25

Atlanta Cancer Care - Atlanta

Atlanta, Georgia, United States, 30342

Actively Recruiting

26

Georgia Cancer Specialists-Northside

Atlanta, Georgia, United States, 30342

Actively Recruiting

27

Northside Hospital, Inc.- Central Research Department

Atlanta, Georgia, United States, 30342

Actively Recruiting

28

Northside Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

29

Georgia Cancer Specialists - Blairsville

Blairsville, Georgia, United States, 30512

Actively Recruiting

30

Georgia Cancer Specialists - Canton

Canton, Georgia, United States, 30115

Actively Recruiting

31

Atlanta Cancer Care - Cumming

Cumming, Georgia, United States, 30041

Actively Recruiting

32

Georgia Cancer Specialists - Cumming

Cumming, Georgia, United States, 30041

Actively Recruiting

33

Georgia Cancer Specialists - Decatur

Decatur, Georgia, United States, 30033

Actively Recruiting

34

Suburban Hematology-Oncology Associates - Duluth

Duluth, Georgia, United States, 30096

Actively Recruiting

35

Suburban Hematology-Oncology Associates- Lawrenceville

Lawrenceville, Georgia, United States, 30046

Actively Recruiting

36

Georgia Cancer Specialists - Macon

Macon, Georgia, United States, 31217

Actively Recruiting

37

Georgia Cancer Specialists - Marietta

Marietta, Georgia, United States, 30060

Actively Recruiting

38

Memorial Hospital

Shiloh, Illinois, United States, 62269

Actively Recruiting

39

Siteman Cancer Center - Shiloh

Shiloh, Illinois, United States, 62269

Actively Recruiting

40

Massachusetts General Hospital.

Boston, Massachusetts, United States, 02114

Actively Recruiting

41

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

42

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

43

Dana Farber Cancer Institute- Chestnut Hill

Newton, Massachusetts, United States, 02459

Actively Recruiting

44

Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

45

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

46

Siteman Cancer Center - North County

Florissant, Missouri, United States, 63031

Actively Recruiting

47

Saint Luke's Cancer Institute LLC

Kansas City, Missouri, United States, 64111

Actively Recruiting

48

Saint Luke's Hospital Investigational Pharmacy

Kansas City, Missouri, United States, 64111

Actively Recruiting

49

Barnes-Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

50

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States, 63110

Actively Recruiting

51

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

52

Siteman Cancer Center - South County

St Louis, Missouri, United States, 63129

Actively Recruiting

53

Renown Regional Medical Center

Reno, Nevada, United States, 89502

Actively Recruiting

54

MSK Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

55

MSK Monmouth.

Middletown, New Jersey, United States, 07748

Actively Recruiting

56

MSK Bergen.

Montvale, New Jersey, United States, 07645

Actively Recruiting

57

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

Terminated

58

MSK Commack.

Commack, New York, United States, 11725

Actively Recruiting

59

MSK Westchester.

Harrison, New York, United States, 10604

Actively Recruiting

60

Investigational Drug Service

Long Island City, New York, United States, 11101

Actively Recruiting

61

Memorial Sloan Kettering Cancer Center - Main Hospital

New York, New York, United States, 10065

Actively Recruiting

62

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

63

MSK Nassau.

Uniondale, New York, United States, 11553

Actively Recruiting

64

Zangmeister Cancer Center

Columbus, Ohio, United States, 43219

Actively Recruiting

65

Saint Francis Hospital / Bon Secours - South Carolina

Greenville, South Carolina, United States, 29607

Actively Recruiting

66

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, United States, 37203

Not Yet Recruiting

67

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Not Yet Recruiting

68

Tennessee Oncology-Nashville/Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Not Yet Recruiting

69

Parkland Health and Hospital System

Dallas, Texas, United States, 75235

Not Yet Recruiting

70

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, United States, 75235

Not Yet Recruiting

71

University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy

Dallas, Texas, United States, 75235

Not Yet Recruiting

72

University of Texas Southwestern Medical Center Simmons Cancer Center - Redbird

Dallas, Texas, United States, 75237

Not Yet Recruiting

73

University of Texas Southwestern Medical Center Clinical Lab-Zale Lipshy University Hospital

Dallas, Texas, United States, 75390

Not Yet Recruiting

74

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

Dallas, Texas, United States, 75390

Not Yet Recruiting

75

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Not Yet Recruiting

76

University of Texas Southwestern Simmons Cancer Center - Fort Worth

Fort Worth, Texas, United States, 76104

Not Yet Recruiting

77

University of Texas Southwestern Medical Center Simmons Cancer Center - Richardson/Plano

Richardson, Texas, United States, 75080

Not Yet Recruiting

78

Harborview Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

79

Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States, 98109

Actively Recruiting

80

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

81

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States, 53718

Actively Recruiting

82

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

83

Peninsula & South Eastern Hematology and Oncology Group (PASO)

Frankston, Victoria, Australia, 3199

Not Yet Recruiting

84

Slade Pharmacy Frankston

Frankston, Victoria, Australia, 3199

Not Yet Recruiting

85

Peninsula & South Eastern Hematology and Oncology Group (PASO)

Frankston, Victoria, Australia

Not Yet Recruiting

86

Slade Health

Mount Waverley, Victoria, Australia, 3149

Not Yet Recruiting

87

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

Not Yet Recruiting

88

BC Cancer Kelowna.

Kelowna, British Columbia, Canada, V1Y 5L3

Actively Recruiting

89

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

90

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

91

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

92

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)

Berlin, Germany, 12203

Actively Recruiting

93

Universitatsklinikum Essen

Essen, Germany, 45147

Actively Recruiting

94

Heidelberg University Hospital and German Cancer Research Center

Heidelberg, Germany, 69120

Actively Recruiting

95

A.O.U. Federico II

Naples, Campania, Italy, 80131

Actively Recruiting

96

Azienda Ospedaliera Universitaria (AOU) Federico II

Naples, Campania, Italy, 80131

Actively Recruiting

97

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.

Naples, Campania, Italy, 80131

Actively Recruiting

98

Istituto Europeo di Oncologia

Milan, Lombardy, Italy, 20141

Actively Recruiting

99

Humanitas Istituto Clinico Catanese

Misterbianco (CT), Sicily, Italy, 95045

Actively Recruiting

100

Azienda Ospedaliera Universitaria Integrata di Verona.

Verona, Veneto, Italy, 37134

Actively Recruiting

101

Niguarda Ca' Granda Hospital

Milan, Italy, 20162

Actively Recruiting

102

A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia

Naples, Italy, 80131

Actively Recruiting

103

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan, 135-8550

Not Yet Recruiting

104

Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan, 135-8550

Not Yet Recruiting

105

Showa University Hospital

Shinagawa-ku, Tokyo-to, Japan, 142-8666

Not Yet Recruiting

106

Okayama University Hospital

Okayama, Japan, 700-8558

Not Yet Recruiting

107

Showa Medical University Hospital

Tokyo, Japan, 142-8666

Not Yet Recruiting

108

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

109

Dong-A University Hospital

Busan, Other, South Korea, 49201

Not Yet Recruiting

110

National Cancer Center

Goyang-si, Other, South Korea, 10408

Actively Recruiting

111

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080

Actively Recruiting

112

Chungbuk National University Hospital

Cheongju-si, South Korea, 28644

Not Yet Recruiting

113

Gachon University Gil Medical Center

Incheon, South Korea, 21565

Not Yet Recruiting

114

Korea University Anam Hospital

Seoul, South Korea, 02841

Actively Recruiting

115

Severance Hospital Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

116

St. Vincent's Hospital, The Catholic University of Korea

Suwon, South Korea, 16247

Not Yet Recruiting

117

Quirén Salud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

118

Hospital Universitari Vall d´Hebron

Barcelona, Spain, 08035

Actively Recruiting

119

Institut Catala d'Oncologia

Barcelona, Spain, 08908

Actively Recruiting

120

CETIR Grup Medic

Barcelona, Spain, 08950

Actively Recruiting

121

Hospital Universitario de Basurto

Bilbao, Spain, 48013

Actively Recruiting

122

Grupo Hospitalario QuironSalud

Erandio Bizkaia, Spain, 48950

Actively Recruiting

123

Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

Madrid, Spain, 28050

Actively Recruiting

124

START Madrid-CIOCC_Hospital HM Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

125

Ecg Medica Sl

Valencia, Spain, 46004

Actively Recruiting

126

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

127

National Cheng Kung University Hospital

Tainan, Taiwan, 704017

Not Yet Recruiting

128

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Not Yet Recruiting

129

National Taiwan University Hospital

Taipei, Taiwan, 100225

Not Yet Recruiting

130

National Taiwan University Hospital

Taipei, Taiwan, 100

Not Yet Recruiting

131

National Taiwan University Cancer Center

Taipei, Taiwan, 106

Not Yet Recruiting

132

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Not Yet Recruiting

133

Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan, 333

Not Yet Recruiting

134

The Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

135

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

136

St Bartholomew's Hospital

London, United Kingdom, EC1M 6BQ

Not Yet Recruiting

137

The Royal Marsden Hospital

London, United Kingdom, SW3 6JJ

Actively Recruiting

138

The Royal Marsden NHS Foundation Trust (RM)

London, United Kingdom, SW3 6JJ

Actively Recruiting

139

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

140

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4GJ

Not Yet Recruiting

141

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT

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

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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