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A Study of Sigvotatug Vedotin in Advanced Solid Tumors
NCT04389632 · Seagen Inc.
In plain English
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Official title
A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
About this study
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
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.
Study design
Enrollment target: 1006 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-06-08
Estimated completion: 2029-03-22
Last updated: 2026-04-07
Interventions
Drug: sigvotatug vedotinDrug: pembrolizumabDrug: cisplatinDrug: carboplatin
Primary outcomes
- • Number of participants with adverse events (AEs) (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)
Sponsor
Seagen, a wholly owned subsidiary of Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (155)
Alaska Oncology and HematologyRecruiting
Anchorage, Alaska, United States
Highlands Oncology GroupRecruiting
Fayetteville, Arkansas, United States
Highlands Oncology GroupRecruiting
Rogers, Arkansas, United States
Highlands Oncology GroupRecruiting
Springdale, Arkansas, United States
Providence Medical FoundationRecruiting
Anaheim, California, United States
Providence Medical FoundationRecruiting
Fullerton, California, United States
Providence St. Jude Medical Center Virginia K Crosson and Infusion CenterRecruiting
Fullerton, California, United States
Cancer and Blood Research Center, LLCNot Yet Recruiting
Los Alamitos, California, United States
Cancer and Blood Specialty ClinicNot Yet Recruiting
Los Alamitos, California, United States
Ronald Reagan UCLA Medical CenterRecruiting
Los Angeles, California, United States
The Regents of the University of CaliforniaRecruiting
Los Angeles, California, United States
UCLA Department of Medicine-Hematology/OncologyRecruiting
Los Angeles, California, United States
UCLA Department of Medicine - Hematology & OncologyRecruiting
Santa Monica, California, United States
Cancer AND Blood Specialty ClinicNot Yet Recruiting
Torrance, California, United States
American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista OncologyRecruiting
Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute, LLCRecruiting
Fort Myers, Florida, United States
Memorial Cancer InstituteRecruiting
Hollywood, Florida, United States
Memorial Healthcare SystemRecruiting
Hollywood, Florida, United States
Florida Cancer SpecialistsRecruiting
Orlando, Florida, United States
Memorial Cancer Institute at Memorial Hospital WestRecruiting
Pembroke Pines, Florida, United States
Memorial Hospital WestRecruiting
Pembroke Pines, Florida, United States
Ingalls Family Care CenterRecruiting
Calumet City, Illinois, United States
UChicago Medicine - River EastRecruiting
Chicago, Illinois, United States
The University Of ChicagoRecruiting
Chicago, Illinois, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
UChicago Medicine at Ingalls - FlossmoorRecruiting
Flossmoor, Illinois, United States
UChicago Medicine Ingalls MemorialRecruiting
Harvey, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross HospitalRecruiting
New Lenox, Illinois, United States
The University of Chicago Medicine Center for Advanced Care Orland ParkRecruiting
Orland Park, Illinois, United States
Southern Illinois University - Simmons Cancer InstituteRecruiting
Springfield, Illinois, United States
Springfield Clinic Radiology - 800 BuildingRecruiting
Springfield, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Springfield Clinic Main CampusRecruiting
Springfield, Illinois, United States
Springfield Clinic Radiology - Main CampusRecruiting
Springfield, Illinois, United States
Springfield Memorial HospitalRecruiting
Springfield, Illinois, United States
UChicago Medicine at Ingalls - Tinley ParkRecruiting
Tinley Park, Illinois, United States
UChicago Medicine - Northwest IndianaRecruiting
Crown Point, Indiana, United States
Fort Wayne Medical Oncology and Hematology, IncRecruiting
Fort Wayne, Indiana, United States
Community Health Network, IncRecruiting
Indianapolis, Indiana, United States
Community Health Network, Inc.Recruiting
Indianapolis, Indiana, United States
Community Health Network Investigational Drug ServicesRecruiting
Indianapolis, Indiana, United States
Community Health Network, Inc.Recruiting
Indianapolis, Indiana, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
The University of Kansas Cancer Center, Investigational Drug ServicesRecruiting
Fairway, Kansas, United States
The University of Kansas Clinical Research CenterRecruiting
Fairway, Kansas, United States
The University of Kansas HospitalRecruiting
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office BuildingRecruiting
Kansas City, Kansas, United States
University of Kansas Hospital Cambridge North Tower ARecruiting
Kansas City, Kansas, United States
University of Kansas Medical Center Research InstituteRecruiting
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek CampusRecruiting
Overland Park, Kansas, United States
The University of Kansas Cancer Center - WestwoodRecruiting
Westwood, Kansas, United States
University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Brigham & Women's HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center,East Campus Research PharmacyRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut HillRecruiting
Newton, Massachusetts, United States
Allina Health Cancer Institute - Mercy HospitalRecruiting
Coon Rapids, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern HospitalRecruiting
Minneapolis, Minnesota, United States
Allina Health Cancer InstituteRecruiting
Saint Paul, Minnesota, United States
Comprehensive Cancer Centers of NevadaRecruiting
Las Vegas, Nevada, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Babylon, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Brooklyn, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
New Hyde Park, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Patchogue, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Port Jefferson Station, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Riverhead, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
Shirley, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRecruiting
The Bronx, New York, United States
University Hospitals Cleveland Medical CenterActive Not Recruiting
Cleveland, Ohio, United States
OU Health University of Oklahoma Medical CenterRecruiting
Oklahoma City, Oklahoma, United States
Stephenson Cancer Center (chemo location)Recruiting
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science CenterRecruiting
Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz ClinicRecruiting
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - WestsideRecruiting
Portland, Oregon, United States
Providence St. Vincent Medical Center- Investigational Drug ServicesRecruiting
Portland, Oregon, United States
Providence St. Vincent Medical CenterRecruiting
Portland, Oregon, United States
Sanford Cancer CenterRecruiting
Sioux Falls, South Dakota, United States
Sanford ResearchRecruiting
Sioux Falls, South Dakota, United States
Sanford USD Medical CenterRecruiting
Sioux Falls, South Dakota, United States
US Oncology Research LLCRecruiting
Nashville, Tennessee, United States
Oncology Consultants, PARecruiting
Houston, Texas, United States
Oncology Consultants, PA.Recruiting
Houston, Texas, United States
The University of Texas M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
US Oncology Investigational Product Center (IPC)Recruiting
Irving, Texas, United States
Houston Medical ImagingNot Yet Recruiting
Pearland, Texas, United States
South Texas Accelerated Research Therapeutics, LLCActive Not Recruiting
San Antonio, Texas, United States
UT Health East Texas HOPE Cancer CenterRecruiting
Tyler, Texas, United States
UT Health East Texas Hope Cancer CenterRecruiting
Tyler, Texas, United States
Tranquil Clinical ResearchNot Yet Recruiting
Webster, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Northwest Medical Specialities. PLLCNot Yet Recruiting
Bonney Lake, Washington, United States
Swedish Cancer Institute - Edmonds CampusRecruiting
Edmonds, Washington, United States
Swedish Cancer Institute Edmonds CampusRecruiting
Edmonds, Washington, United States
Northwest Medical Specialities.PLLCNot Yet Recruiting
Federal Way, Washington, United States
Northwest Medical Specialities. PLLCNot Yet Recruiting
Gig Harbor, Washington, United States
American Oncology Network Vista Oncology Division-West officeRecruiting
Olympia, Washington, United States
American Oncology Network Vista Oncology Division-East officeRecruiting
Olympia, Washington, United States
Northwest Medical Specialties, PPLCNot Yet Recruiting
Puyallup, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Exigent Research, LLCNot Yet Recruiting
Tacoma, Washington, United States
Northwest Medical Specialities, PLLCNot Yet Recruiting
Tacoma, Washington, United States
Center Hospitalier Universitaire d' AngersActive Not Recruiting
Angers, France
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine LacassagneRecruiting
Nice, France
Centre Hospitalier Universitaire de PoitiersRecruiting
Poitiers, France
Institut de Cancérologie de LorraineRecruiting
Vandœuvre-lès-Nancy, France
lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)Recruiting
Villejuif, France
National Cancer CenterRecruiting
Goyang-si, Gyeonggi-do, South Korea
Chungbuk National University HospitalRecruiting
Cheongju-si, North Chungcheong, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Samsung Medical CenterNot Yet Recruiting
Seoul, South Korea
The Catholic University of KoreaRecruiting
Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Farmacia Ensayos Hospital HM Universitario SanchinarroRecruiting
Madrid, Agrigento, Spain
Elche General University HospitalRecruiting
Elche, Alicante, Spain
Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario MarquésRecruiting
Santander, Cantabria, Spain
Hospital HM Nou DelfosRecruiting
Barcelona, Catalonia, Spain
Fundación Privada Instituto de Investigación Oncológica de Vall HebronRecruiting
Barcelona, Other, Spain
NEXT Oncology Barcelona - IOB - Hospital Quironsalud BarcelonaRecruiting
Barcelona, OTH, Spain
Farmacia Ensayos clínicos, Unidad START BarcelonaRecruiting
Barcelona, Spain
Hospital HM Nou Delfos - START BarcelonaRecruiting
Barcelona, Spain
Hospital Quiron Salud BarcelonaRecruiting
Barcelona, Spain
Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer "la Caixa"Recruiting
Barcelona, Spain
Hospital Vall d'HebronRecruiting
Barcelona, Spain
Elche General University HospitalRecruiting
Elche, Spain
Hospital Universitario De JerezRecruiting
Jerez de la Frontera, Spain
UGC Farmacia Ensayos clinicos - Hospital Universitario de JerezRecruiting
Jerez de la Frontera, Spain
Hospital Universitario de JerezRecruiting
Jerez de la Frontera, Spain
Fundación de Investigación Hm Hospitales, C.I.F. G-83643841Recruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Servicio de Radiologia Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario 12 OctubreRecruiting
Madrid, Spain
Hospital HM Sanchinarro, START-Madrid-CIOCCRecruiting
Madrid, Spain
Quironsalud MalagaRecruiting
Málaga, Spain
Kantonsspital GraubundenRecruiting
Chur, Switzerland
University Hospital Lausanne CHUVRecruiting
Lausanne, Switzerland
CHUV - Service de pharmacie BH-04, Essais cliniquesRecruiting
Lausanne, Switzerland
Kaohsiung Medical University HospitalRecruiting
Kaohsiung City, R.o.c., Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital.Recruiting
Taipei, Taiwan
The Royal Marsden Hospital (Surrey)Recruiting
Sutton, Queensland, United Kingdom
Royal Marsden HospitalRecruiting
Sutton, Surrey, United Kingdom
Queen Elizabeth HospitalRecruiting
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation TrustRecruiting
Birmingham, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
London, United Kingdom
Sarah Cannon Research InstituteRecruiting
London, United Kingdom
Diagnostic centreRecruiting
London, United Kingdom
The Harley Street ClinicRecruiting
London, United Kingdom
RadiologyRecruiting
London, United Kingdom