A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors

Who is this study for? Adult patients with Solid Tumors
What treatments are being studied? SGN-B6A
Status: Recruiting
Location: See all (133) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Oncology and Hematology
NOT_YET_RECRUITING
Anchorage
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
California
Providence Medical Foundation
RECRUITING
Fullerton
Providence St. Jude Medical Center Virginia K Crosson and Infusion Center
RECRUITING
Fullerton
Cancer and Blood Research Center, LLC
NOT_YET_RECRUITING
Los Alamitos
Cancer and Blood Specialty Clinic
NOT_YET_RECRUITING
Los Alamitos
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
UCLA Department of Medicine-Hematology/Oncology
RECRUITING
Los Angeles
UCLA Department of Medicine - Hematology & Oncology
RECRUITING
Santa Monica
Cancer AND Blood Specialty Clinic
NOT_YET_RECRUITING
Torrance
Florida
Memorial Cancer Institute
RECRUITING
Hollywood
Memorial Healthcare System
RECRUITING
Hollywood
Florida cancer Specialists
RECRUITING
Orlando
Memorial Hospital West
RECRUITING
Pembroke Pines
Illinois
Ingalls Family Care Center
RECRUITING
Calumet City
UChicago Medicine - River East
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
UChicago Medicine at Ingalls - Flossmoor
RECRUITING
Flossmoor
UChicago Medicine Ingalls Memorial
RECRUITING
Harvey
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
RECRUITING
New Lenox
The University of Chicago Medicine Center for Advanced Care Orland Park
RECRUITING
Orland Park
Southern Illinois University - Simmons Cancer Institute
RECRUITING
Springfield
Springfield Clinic
NOT_YET_RECRUITING
Springfield
Springfield Clinic Radiology - 800 Building
NOT_YET_RECRUITING
Springfield
Springfield Clinic Radiology - Main Campus
NOT_YET_RECRUITING
Springfield
UChicago Medicine at Ingalls - Tinley Park
RECRUITING
Tinley Park
Indiana
UChicago Medicine - Northwest Indiana
RECRUITING
Crown Point
Fort Wayne Medical Oncology and Hematology, Inc
NOT_YET_RECRUITING
Fort Wayne
Community Health Network
RECRUITING
Indianapolis
Community Health Network
RECRUITING
Indianapolis
Community Health Network Investigational Drug Services
RECRUITING
Indianapolis
Community Health Network, Inc
RECRUITING
Indianapolis
Kansas
The University of Kansas Cancer Center, Investigational Drug Services
RECRUITING
Fairway
The University of Kansas Clinical Research Center
RECRUITING
Fairway
The University of Kansas Hospital
RECRUITING
Kansas City
The University of Kansas Medical Center Medical Office Building
RECRUITING
Kansas City
University of Kansas Hospital Cambridge North Tower A
RECRUITING
Kansas City
The University of Kansas Cancer Center - Indian Creek Campus
RECRUITING
Overland Park
The University of Kansas Cancer Center - Westwood
RECRUITING
Westwood
University of Kansas Cancer Center
RECRUITING
Westwood
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Beth Israel Deaconess Medical Center,East Campus Research Pharmacy
RECRUITING
Boston
Dana-Farber Cancer Institute - Chestnut Hill
RECRUITING
Newton
Minnesota
Allina Health Cancer Institute - Mercy Hospital
RECRUITING
Coon Rapids
Allina Health Cancer Institute - Abbott Northwestern Hospital
RECRUITING
Minneapolis
Allina Health Cancer Institute
RECRUITING
Saint Paul
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Babylon
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Brooklyn
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
New Hyde Park
Columbia University Irving Medical Center
RECRUITING
New York
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
New York
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Patchogue
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Port Jefferson Station
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Riverhead
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Shirley
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
The Bronx
Ohio
University Hospitals Cleveland Medical Center
ACTIVE_NOT_RECRUITING
Cleveland
Oklahoma
OU Health University of Oklahoma Medical Center
NOT_YET_RECRUITING
Oklahoma City
Stephenson Cancer Center (chemo location)
NOT_YET_RECRUITING
Oklahoma City
University of Oklahoma Health Science Center
NOT_YET_RECRUITING
Oklahoma City
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Providence Oncology and Hematology Care Clinic - Westside
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
Providence St. Vincent Medical Center- Investigational Drug Services
RECRUITING
Portland
South Dakota
Sanford Cancer Center
RECRUITING
Sioux Falls
Sanford USD Medical Center
RECRUITING
Sioux Falls
Texas
Oncology Consultants, PA
RECRUITING
Houston
Oncology Consultants, PA.
RECRUITING
Houston
The University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
US Oncology Investigational Product Center (IPC)
RECRUITING
Irving
Houston Medical Imaging
NOT_YET_RECRUITING
Pearland
South Texas Accelerated Research Therapeutics, LLC
ACTIVE_NOT_RECRUITING
San Antonio
UT Health East Texas Hope Cancer Center
NOT_YET_RECRUITING
Tyler
UT Health East Texas HOPE Cancer Center
NOT_YET_RECRUITING
Tyler
Tranquil Clinical Research
NOT_YET_RECRUITING
Webster
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Swedish Cancer Institute - Edmonds Campus
RECRUITING
Edmonds
Swedish Cancer Institute Edmonds Campus
RECRUITING
Edmonds
American Oncology Network Vista Oncology Division-East office
RECRUITING
Olympia
American Oncology Network Vista Oncology Division-West office
RECRUITING
Olympia
Swedish Cancer Institute
RECRUITING
Seattle
Swedish Medical Center
RECRUITING
Seattle
Northwest Medical Specialities, PLLC
NOT_YET_RECRUITING
Tacoma
Other Locations
France
Center Hospitalier Universitaire d' Angers
RECRUITING
Angers
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING
Moselle
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
RECRUITING
Nice
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)
RECRUITING
Villejuif
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
National Cancer Center
RECRUITING
Goyang-si
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea
RECRUITING
Seoul
Spain
Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer la Caixa
RECRUITING
Barcelona
Farmacia Ensayos clínicos, Unidad START Barcelona
RECRUITING
Barcelona
Hospital HM Nou Delfos
RECRUITING
Barcelona
Hospital HM Nou Delfos - START Barcelona
RECRUITING
Barcelona
Hospital Quiron Salud Barcelona
RECRUITING
Barcelona
Hospital Vall d'Hebron
RECRUITING
Barcelona
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
RECRUITING
Barcelona
Elche General University Hospital
RECRUITING
Elche
Elche General University Hospital
RECRUITING
Elche
Hospital Universitario de Jerez
RECRUITING
Jerez De La Frontera
Hospital Universitario De Jerez
RECRUITING
Jerez De La Frontera
UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez
RECRUITING
Jerez De La Frontera
Farmacia Ensayos Hospital HM Universitario Sanchinarro
RECRUITING
Madrid
Hospital HM Sanchinarro, START-Madrid-CIOCC
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Servicio de Radiologia Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Quironsalud Malaga
RECRUITING
Málaga
Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario Marqués
RECRUITING
Santander
Switzerland
Kantonsspital Graubunden
RECRUITING
Chur
CHUV - Service de pharmacie BH-04, Essais cliniques
RECRUITING
Lausanne
University Hospital Lausanne CHUV
RECRUITING
Lausanne
Taiwan
Kaohsiung Medical University Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital.
RECRUITING
Taipei
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Diagnostic centre
RECRUITING
London
Radiology
RECRUITING
London
Sarah Cannon Research Institute
RECRUITING
London
The Harley Street Clinic
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
Royal Marsden Hospital
RECRUITING
Sutton
The Royal Marsden Hospital (Surrey)
RECRUITING
Sutton
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2020-06-08
Estimated Completion Date: 2029-03-22
Participants
Target number of participants: 1006
Treatments
Experimental: Part A: Dose escalation
sigvotatug vedotin monotherapy
Experimental: Part B: Dose expansion
sigvotatug vedotin monotherapy
Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov

Similar Clinical Trials