A Study of Sigvotatug Vedotin in Advanced Solid Tumors
A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
3 other identifiers
interventional
1,006
7 countries
158
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2020
Longer than P75 for phase_1
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
June 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 22, 2029
April 20, 2026
April 1, 2026
7 years
May 12, 2020
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Number of patients with laboratory abnormalities
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Secondary Outcomes (11)
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Up to approximately 3 years
Overall survival (OS)
Up to approximately 3 years
Area under the concentration-time curve (AUC)
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
- +6 more secondary outcomes
Study Arms (5)
Part A: Dose escalation
EXPERIMENTALsigvotatug vedotin monotherapy
Part B: Dose expansion
EXPERIMENTALsigvotatug vedotin monotherapy
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
EXPERIMENTALsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
EXPERIMENTALsigvotatug vedotin + pembrolizumab +/- (carboplatin)
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
EXPERIMENTALsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Interventions
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Administered into the vein (IV; intravenously)
75 mg/m2 every 3 weeks, given by IV
AUC 5 mg/mL per min every 3 weeks, given by IV
Eligibility Criteria
You may qualify if:
- 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.
- +7 more criteria
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
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
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
Community Health Network
Indianapolis, Indiana, 46256, 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
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 Research
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
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
Samsung Medical Center
Seoul, 06351, 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 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
NEXT Oncology - IOB Hospital Quironsalud 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
Related Publications (1)
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.
PMID: 37619980DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
June 8, 2020
Primary Completion (Estimated)
June 16, 2027
Study Completion (Estimated)
March 22, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.