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NCT04389632PHASE1Recruiting

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer

Start Date

6/8/2020

Completion Date

3/22/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Disease indication * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part). * Non-small cell lung cancer (NSCLC) * Head and neck squamous cell cancer (HNSCC) * Advanced HER2-negative breast cancer * Esophageal squamous cell carcinoma (ESCC) * Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ) * Cutaneous squamous cell cancer (cSCC) * Exocrine pancreatic adenocarcinoma * Bladder cancer * Cervical cancer * Gastric cancer * High grade serous ovarian cancer (HGSOC) * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options. * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available. * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed). * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy. * Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows: * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used. * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Measurable disease per the RECIST v1.1 at baseline Exclusion Criteria * History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * 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 associated with brain metastases for at least 7 days prior to first dose of study drug. * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids. * Carcinomatous meningitis * Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6 * Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts * Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin. * Routine antimicrobial prophylaxis is permitted * Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses * Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE). * History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening * Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Interventions

DRUG

sigvotatug vedotin

DRUG

pembrolizumab

DRUG

cisplatin

DRUG

carboplatin

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Conditions

Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaOvarian NeoplasmsCutaneous Squamous Cell CancerExocrine Pancreatic AdenocarcinomaUrinary Bladder NeoplasmsUterine Cervical NeoplasmsStomach Neoplasms

Locations

Alaska Oncology and Hematology

Anchorage, Alaska 99508

United States

Highlands Oncology Group

Fayetteville, Arkansas 72703

United States

Highlands Oncology Group

Rogers, Arkansas 72758

United States

Highlands Oncology Group

Springdale, Arkansas 72762

United States

Providence Medical Foundation

Anaheim, California 92805

United States

Providence Medical Foundation

Fullerton, California 92835

United States

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

Fullerton, California 92835

United States

Cancer and Blood Research Center, LLC

Los Alamitos, California 90720

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

The Regents of the University of California

Los Angeles, California 90095

United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California 90095

United States

UCLA Department of Medicine - Hematology & Oncology

Santa Monica, California 90404

United States

Cancer AND Blood Specialty Clinic

Torrance, California 90505

United States

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

Fort Myers, Florida 33913

United States

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida 33916

United States

Memorial Cancer Institute

Hollywood, Florida 33021

United States

Memorial Healthcare System

Hollywood, Florida 33021

United States

Florida Cancer Specialists

Orlando, Florida 32827

United States

Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida 33028

United States

Memorial Hospital West

Pembroke Pines, Florida 33028

United States

Ingalls Family Care Center

Calumet City, Illinois 60409

United States

UChicago Medicine - River East

Chicago, Illinois 60611

United States

The University Of Chicago

Chicago, Illinois 60637

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois 60422

United States

UChicago Medicine Ingalls Memorial

Harvey, Illinois 60426

United States

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois 60451

United States

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois 60462

United States

Southern Illinois University - Simmons Cancer Institute

Springfield, Illinois 62702

United States

Springfield Clinic Radiology - 800 Building

Springfield, Illinois 62702

United States

Springfield Clinic Urgent Care Plus

Springfield, Illinois 62702

United States

Springfield Clinic

Springfield, Illinois 62702

United States

Springfield Clinic Main Campus

Springfield, Illinois 62703

United States

Springfield Clinic Radiology - Main Campus

Springfield, Illinois 62703

United States

Springfield Memorial Hospital

Springfield, Illinois 62781

United States

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois 60477

United States

UChicago Medicine - Northwest Indiana

Crown Point, Indiana 46307

United States

Fort Wayne Medical Oncology and Hematology, Inc

Fort Wayne, Indiana 46804

United States

Community Health Network, Inc

Indianapolis, Indiana 46219

United States

Community Health Network, Inc.

Indianapolis, Indiana 46227

United States

Community Health Network Investigational Drug Services

Indianapolis, Indiana 46250

United States

Community Health Network, Inc.

Indianapolis, Indiana 46250

United States

The University of Kansas Cancer Center, Investigational Drug Services

Fairway, Kansas 66205

United States

The University of Kansas Clinical Research Center

Fairway, Kansas 66205

United States

The University of Kansas Hospital

Kansas City, Kansas 66160

United States

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas 66160

United States

University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas 66160

United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas 66160

United States

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas 66211

United States

The University of Kansas Cancer Center - Westwood

Westwood, Kansas 66205

United States

University of Kansas Cancer Center

Westwood, Kansas 66205

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham & Women's Hospital

Boston, Massachusetts 02115

United States

Beth Israel Deaconess Medical Center,East Campus Research Pharmacy

Boston, Massachusetts 02215

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts 02467

United States

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

Allina Health Cancer Institute - United Hospital

Saint Paul, Minnesota 55102

United States

Allina Health Cancer Institute

Saint Paul, Minnesota 55102

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169

United States

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

Babylon, New York 11702

United States

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

Brooklyn, New York 11210

United States

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

New Hyde Park, New York 11042

United States

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

New York, New York 10028

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

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

Patchogue, New York 11772

United States

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

Port Jefferson Station, New York 11776

United States

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

Riverhead, New York 11901

United States

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

Shirley, New York 11967

United States

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

The Bronx, New York 10469

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma 73104

United States

Stephenson Cancer Center (chemo location)

Oklahoma City, Oklahoma 73104

United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma 73104

United States

Providence Cancer Institute Franz Clinic

Portland, Oregon 97213

United States

Providence Oncology and Hematology Care Clinic - Westside

Portland, Oregon 97225

United States

Providence St. Vincent Medical Center- Investigational Drug Services

Portland, Oregon 97225

United States

Providence St. Vincent Medical Center

Portland, Oregon 97225

United States

Sanford Cancer Center

Sioux Falls, South Dakota 57104

United States

Sanford USD Medical Center

Sioux Falls, South Dakota 57105

United States

US Oncology Research LLC

Nashville, Tennessee 37203

United States

Oncology Consultants, PA

Houston, Texas 77024

United States

Oncology Consultants, PA.

Houston, Texas 77030

United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas 77030

United States

US Oncology Investigational Product Center (IPC)

Irving, Texas 75063

United States

Houston Medical Imaging

Pearland, Texas 77581

United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas 78229

United States

UT Health East Texas HOPE Cancer Center

Tyler, Texas 75701

United States

UT Health East Texas Hope Cancer Center

Tyler, Texas 75708

United States

Tranquil Clinical Research

Webster, Texas 77598

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Northwest Medical Specialities. PLLC

Bonney Lake, Washington 98391

United States

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington 98026

United States

Swedish Cancer Institute Edmonds Campus

Edmonds, Washington 98026

United States

Northwest Medical Specialities.PLLC

Federal Way, Washington 98003

United States

Northwest Medical Specialities. PLLC

Gig Harbor, Washington 98332

United States

American Oncology Network Vista Oncology Division-West office

Olympia, Washington 98502

United States

American Oncology Network Vista Oncology Division-East office

Olympia, Washington 98506

United States

Northwest Medical Specialties, PPLC

Puyallup, Washington 98373

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Swedish Medical Center

Seattle, Washington 98122

United States

Exigent Research, LLC

Tacoma, Washington 98405

United States

Northwest Medical Specialities, PLLC

Tacoma, Washington 98405

United States

Center Hospitalier Universitaire d' Angers

Angers, 49100

France

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

Nice, 06189

France

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021

France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519

France

Institut Gustave Roussy Department de Pharmacie Clinique(-1)

Villejuif, 94805.

France

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

Villejuif, 94805.

France

National Cancer Center

Goyang-si, Gyeonggi-do 10408

South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong 28644

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

The Catholic University of Korea

Seoul, 06591

South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Farmacia Ensayos Hospital HM Universitario Sanchinarro

Madrid, Agrigento 28050

Spain

Elche General University Hospital

Elche, Alicante 03203

Spain

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

Santander, Cantabria 39008

Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008

Spain

Hospital HM Nou Delfos

Barcelona, Catalonia 08023

Spain

Fundación Privada Instituto de Investigación Oncológica de Vall Hebron

Barcelona, Other 08035

Spain

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, OTH 08023

Spain

Elche General University Hospital

Elche, Valencia 03203

Spain

Hospital General Universitario de Elche

Elche, Valencia 03203

Spain

Farmacia Ensayos clínicos, Unidad START Barcelona

Barcelona, 08023

Spain

Hospital HM Nou Delfos - START Barcelona

Barcelona, 08023

Spain

Hospital Quiron Salud Barcelona

Barcelona, 08023

Spain

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

Barcelona, 08035

Spain

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Elche General University Hospital

Elche, 03203

Spain

Hospital Universitario De Jerez

Jerez de la Frontera, 10407

Spain

UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez

Jerez de la Frontera, 10407

Spain

Hospital Universitario de Jerez

Jerez de la Frontera, 11407

Spain

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

Madrid, 28015

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Servicio de Radiologia Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario 12 Octubre

Madrid, 28041

Spain

Hospital HM Sanchinarro, START-Madrid-CIOCC

Madrid, 28050

Spain

Quironsalud Malaga

Málaga, 129004

Spain

Kantonsspital Graubunden

Chur, 7000

Switzerland

University Hospital Lausanne CHUV

Lausanne, 1011

Switzerland

CHUV - Service de pharmacie BH-04, Essais cliniques

Lausanne, CH-1011

Switzerland

Kaohsiung Medical University Hospital

Kaohsiung City, R.o.c. 80756

Taiwan

National Taiwan University Hospital

Taipei, 100, R.O.C

Taiwan

Taipei Veterans General Hospital.

Taipei, 11217

Taiwan

The Royal Marsden Hospital (Surrey)

Sutton, Queensland SM2 5PT

United Kingdom

Royal Marsden Hospital

Sutton, Surrey SM2 5PT

United Kingdom

Queen Elizabeth Hospital

Birmingham, B15 2TH

United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH

United Kingdom

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ

United Kingdom

Sarah Cannon Research Institute

London, W1G 6AD

United Kingdom

Diagnostic centre

London, W1G 7AF

United Kingdom

The Harley Street Clinic

London, W1G 8BJ

United Kingdom

Radiology

London, W1G 8PP

United Kingdom