Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
1006 participants
INTERVENTIONAL
2020-06-08
2029-03-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
NCT05194072
Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
NCT03485209
A Study of SGN-ALPV in Advanced Solid Tumors
NCT05229900
A Safety Study of SGN-CD47M in Patients With Solid Tumors
NCT03957096
Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors
NCT06362590
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: Dose escalation
sigvotatug vedotin monotherapy
sigvotatug vedotin
Administered into the vein (IV; intravenously)
Part B: Dose expansion
sigvotatug vedotin monotherapy
sigvotatug vedotin
Administered into the vein (IV; intravenously)
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
sigvotatug vedotin
Administered into the vein (IV; intravenously)
pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
cisplatin
75 mg/m2 every 3 weeks, given by IV
carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
sigvotatug vedotin
Administered into the vein (IV; intravenously)
pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
sigvotatug vedotin
Administered into the vein (IV; intravenously)
pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
cisplatin
75 mg/m2 every 3 weeks, given by IV
carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sigvotatug vedotin
Administered into the vein (IV; intravenously)
pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
cisplatin
75 mg/m2 every 3 weeks, given by IV
carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Florida cancer Specialists
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 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
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States
Swedish Cancer Institute Edmonds Campus
Edmonds, 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
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
Institut de Cancérologie de Lorraine
Moselle, , France
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
Nice, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , 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, , 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 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
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, OTH, Spain
Farmacia Ensayos clínicos, Unidad START Barcelona
Barcelona, , Spain
Hospital HM Nou Delfos - START Barcelona
Barcelona, , Spain
Hospital Quiron Salud 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Lyon RP, Jonas M, Frantz C, Trueblood ES, Yumul R, Westendorf L, Hale CJ, Stilwell JL, Yeddula N, Snead KM, Kumar V, Patilea-Vrana GI, Klussman K, Ryan MC. SGN-B6A: A New Vedotin Antibody-Drug Conjugate Directed to Integrin Beta-6 for Multiple Carcinoma Indications. Mol Cancer Ther. 2023 Dec 1;22(12):1444-1453. doi: 10.1158/1535-7163.MCT-22-0817.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C5751001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508469-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGNB6A-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.