RecruitingPhase 1NCT04389632

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors


Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

1,006 participants

Start Date

Jun 8, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests sigvotatug vedotin, an antibody-drug conjugate that targets a protein called integrin beta-6 found on many cancer cells, in people with various advanced solid tumors. Different parts of the study test it alone or in combination with other treatments such as pembrolizumab. **You may be eligible if...** - You are 18 or older - You have a confirmed metastatic or unresectable solid cancer from one of these types: non-small cell lung cancer, head and neck squamous cell cancer, breast cancer (HER2-negative), esophageal cancer, gastric cancer, bladder cancer, cervical cancer, pancreatic cancer, ovarian cancer, or skin squamous cell cancer - Your cancer has progressed on standard treatments (requirements vary by study part) - Your overall health is good (ECOG 0-1) with measurable disease on imaging **You may NOT be eligible if...** - You have active brain metastases - You have previously received MMAE-containing therapies or drugs targeting integrin beta-6 - You have significant pre-existing nerve damage (neuropathy grade 2 or higher) - You have a history of lung disease (interstitial lung disease or pneumonitis requiring steroids) - You have lung function below 50% capacity - You have active uncontrolled serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsigvotatug vedotin

Administered into the vein (IV; intravenously)

DRUGpembrolizumab

200mg every 3 weeks or 400mg every 6 weeks, given by IV

DRUGcisplatin

75 mg/m2 every 3 weeks, given by IV

DRUGcarboplatin

AUC 5 mg/mL per min every 3 weeks, given by IV


Locations(158)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Providence Medical Foundation

Anaheim, California, United States

Providence Medical Foundation

Fullerton, California, United States

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

Fullerton, California, United States

Cancer and Blood Research Center, LLC

Los Alamitos, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

The Regents of the University of California

Los Angeles, California, United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, United States

UCLA Department of Medicine - Hematology & Oncology

Santa Monica, California, United States

Cancer AND Blood Specialty Clinic

Torrance, California, United States

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

Fort Myers, Florida, United States

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, United States

Memorial Cancer Institute

Hollywood, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Florida Cancer Specialists

Orlando, Florida, United States

Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida, United States

Memorial Hospital West

Pembroke Pines, Florida, United States

Ingalls Family Care Center

Calumet City, Illinois, United States

UChicago Medicine - River East

Chicago, Illinois, United States

The University Of Chicago

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, United States

UChicago Medicine Ingalls Memorial

Harvey, Illinois, United States

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, United States

Southern Illinois University - Simmons Cancer Institute

Springfield, Illinois, United States

Springfield Clinic Radiology - 800 Building

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Clinic Main Campus

Springfield, Illinois, United States

Springfield Clinic Radiology - Main Campus

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, United States

UChicago Medicine - Northwest Indiana

Crown Point, Indiana, United States

Fort Wayne Medical Oncology and Hematology, Inc

Fort Wayne, Indiana, United States

Community Health Network, Inc

Indianapolis, Indiana, United States

Community Health Network, Inc.

Indianapolis, Indiana, United States

Community Health Network Investigational Drug Services

Indianapolis, Indiana, United States

Community Health Network, Inc.

Indianapolis, Indiana, United States

Community Health Network

Indianapolis, Indiana, United States

The University of Kansas Cancer Center, Investigational Drug Services

Fairway, Kansas, United States

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States

University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, United States

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center,East Campus Research Pharmacy

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, United States

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Allina Health Cancer Institute

Saint Paul, Minnesota, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

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

Babylon, New York, United States

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

Brooklyn, New York, United States

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

New Hyde Park, New York, United States

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

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

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

Patchogue, New York, United States

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

Port Jefferson Station, New York, United States

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

Riverhead, New York, United States

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

Shirley, New York, United States

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

The Bronx, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Stephenson Cancer Center (chemo location)

Oklahoma City, Oklahoma, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Providence Oncology and Hematology Care Clinic - Westside

Portland, Oregon, United States

Providence St. Vincent Medical Center- Investigational Drug Services

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Sanford Research

Sioux Falls, South Dakota, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

US Oncology Research LLC

Nashville, Tennessee, United States

Oncology Consultants, PA

Houston, Texas, United States

Oncology Consultants, PA.

Houston, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

US Oncology Investigational Product Center (IPC)

Irving, Texas, United States

Houston Medical Imaging

Pearland, Texas, United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

UT Health East Texas HOPE Cancer Center

Tyler, Texas, United States

UT Health East Texas Hope Cancer Center

Tyler, Texas, United States

Tranquil Clinical Research

Webster, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Northwest Medical Specialities. PLLC

Bonney Lake, Washington, United States

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, United States

Swedish Cancer Institute Edmonds Campus

Edmonds, Washington, United States

Northwest Medical Specialities.PLLC

Federal Way, Washington, United States

Northwest Medical Specialities. PLLC

Gig Harbor, Washington, United States

American Oncology Network Vista Oncology Division-West office

Olympia, Washington, United States

American Oncology Network Vista Oncology Division-East office

Olympia, Washington, United States

Northwest Medical Specialties, PPLC

Puyallup, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Exigent Research, LLC

Tacoma, Washington, United States

Northwest Medical Specialities, PLLC

Tacoma, Washington, United States

Center Hospitalier Universitaire d' Angers

Angers, France

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

Nice, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

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

Villejuif, France

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea

Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Farmacia Ensayos Hospital HM Universitario Sanchinarro

Madrid, Agrigento, Spain

Elche General University Hospital

Elche, Alicante, Spain

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

Santander, Cantabria, Spain

Hospital HM Nou Delfos

Barcelona, Catalonia, Spain

Fundación Privada Instituto de Investigación Oncológica de Vall Hebron

Barcelona, Other, Spain

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, OTH, Spain

Elche General University Hospital

Elche, Valencia, Spain

Hospital General Universitario de Elche

Elche, Valencia, Spain

Farmacia Ensayos clínicos, Unidad START Barcelona

Barcelona, Spain

Hospital HM Nou Delfos - START Barcelona

Barcelona, Spain

Hospital Quiron Salud Barcelona

Barcelona, Spain

NEXT Oncology - IOB Hospital Quironsalud Barcelona

Barcelona, Spain

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

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Elche General University Hospital

Elche, Spain

Hospital Universitario De Jerez

Jerez de la Frontera, Spain

UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

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

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Servicio de Radiologia Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario 12 Octubre

Madrid, Spain

Hospital HM Sanchinarro, START-Madrid-CIOCC

Madrid, Spain

Quironsalud Malaga

Málaga, Spain

Kantonsspital Graubunden

Chur, Switzerland

University Hospital Lausanne CHUV

Lausanne, Switzerland

CHUV - Service de pharmacie BH-04, Essais cliniques

Lausanne, Switzerland

Kaohsiung Medical University Hospital

Kaohsiung City, R.o.c., Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital.

Taipei, Taiwan

The Royal Marsden Hospital (Surrey)

Sutton, Queensland, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

Diagnostic centre

London, United Kingdom

The Harley Street Clinic

London, United Kingdom

Radiology

London, United Kingdom

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NCT04389632


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