Trial Title:
A Study of SGN-B6A in Advanced Solid Tumors
NCT ID:
NCT04389632
Condition:
Carcinoma, Non-Small Cell Lung
Squamous Cell Carcinoma of Head and Neck
HER2 Negative Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Ovarian Neoplasms
Cutaneous Squamous Cell Cancer
Exocrine Pancreatic Adenocarcinoma
Urinary Bladder Neoplasms
Uterine Cervical Neoplasms
Stomach Neoplasms
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Squamous Cell
Ovarian Neoplasms
Stomach Neoplasms
Squamous Cell Carcinoma of Head and Neck
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Carboplatin
Pembrolizumab
Conditions: Keywords:
NSCLC
HNSCC
cSCC
ESCC
EAC
GEJ
HGSOC
Advanced HER2-Negative Breast Cancer
High Grade Serous Ovarian Cancer
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Cancer
Esophageal Cancer
Bladder Cancer
Cervical Cancer
Gastric Cancer
Seattle Genetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sigvotatug vedotin
Description:
Administered into the vein (IV; intravenously)
Arm group label:
Part A: Dose escalation
Arm group label:
Part B: Dose expansion
Arm group label:
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
Other name:
SGN-B6A
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Arm group label:
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
cisplatin
Description:
75 mg/m2 every 3 weeks, given by IV
Arm group label:
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Intervention type:
Drug
Intervention name:
carboplatin
Description:
AUC 5 mg/mL per min every 3 weeks, given by IV
Arm group label:
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Arm group label:
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
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.
Criteria for 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.
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Wyckoff
Phone:
907-257-9851
Email:
talia@alaskaoncology.com
Investigator:
Last name:
Steven Liu, MD
Email:
Principal Investigator
Facility:
Name:
Highlands Oncology Group
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joseph Beck
Phone:
479-587-1700
Email:
research@hogonc.com
Investigator:
Last name:
J. Thaddeus Beck
Email:
Principal Investigator
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Yung Lyou
Email:
Principal Investigator
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
92720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kirsten Bettino
Email:
kbettino@cbsclinic.com
Investigator:
Last name:
Vu Phan
Email:
Principal Investigator
Facility:
Name:
Memorial Cancer Institute
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Luis Raez
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - Lake Nona
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Acker
Phone:
689-216-8500
Email:
Ingrid.Acker@scri.com
Investigator:
Last name:
Cesar Perez Batista, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Cancer Institute
Address:
City:
Pembroke Pines
Zip:
33028
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shoria Martelly
Phone:
954-844-9917
Email:
SMartelly@mhs.net
Investigator:
Last name:
Luis Raez
Email:
Principal Investigator
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637-1470
Country:
United States
Status:
Recruiting
Contact:
Last name:
Glenna Smith
Phone:
773-834-2895
Email:
gsmith6@bsd.uchicago.edu
Investigator:
Last name:
Ari Rosenberg, MD
Email:
Principal Investigator
Facility:
Name:
Ft Wayne Medical Oncology and Hematology, Inc TRIO
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Completed
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
University of Kansas Cancer Center Nurse Inbox
Phone:
913-945-7552
Email:
CTNurseNav@kumc.edu
Investigator:
Last name:
Chao H Huang
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alisa Posner
Phone:
617-975-7423
Email:
aposner1@bidmc.harvard.edu
Investigator:
Last name:
Bruno Bockorny, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Illya Dixon
Phone:
617-632-5084
Email:
Illya_Dixon@dfci.harvard.edu
Investigator:
Last name:
Kartik Sehgal
Email:
Principal Investigator
Facility:
Name:
Allina Health Cancer Institute
Address:
City:
Saint Paul
Zip:
55102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennie Schletty
Phone:
612-863-8950
Email:
jennie.schletty@allina.com
Investigator:
Last name:
Charlene Fares
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edwin C Kingsley
Phone:
702-952-3400
Email:
edwin.kingsley@usoncology.com
Investigator:
Last name:
Edwin C Kingsley
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Bronx
Zip:
10469
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Richard Zuniga
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Richard Zuniga
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
New York
Zip:
10028
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Richard Zuniga
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Shirley
Zip:
11967
Country:
United States
Status:
Recruiting
Contact:
Last name:
New York Cancer and Blood Specialists Research Mailbox
Email:
Research@nycancer.com
Investigator:
Last name:
Richard Zuniga
Email:
Principal Investigator
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Boland
Phone:
216-286-3379
Email:
Megan.Boland@UHhospitals.org
Investigator:
Last name:
Afshin Dowlati
Email:
Principal Investigator
Facility:
Name:
Oklahoma University at Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joanna Overton
Phone:
405-271-8001 x52123
Email:
Joanna.Overton@ouhealth.com
Investigator:
Last name:
Abdul Rafeh Naqash, MD
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Providence Cancer Institute CT.Gov Contact
Phone:
503-215-2614
Email:
CanClinRsrchStudies@providence.org
Investigator:
Last name:
Rachel E Sanborn
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Rachel E Sanborn
Email:
Principal Investigator
Facility:
Name:
Sanford Cancer Center
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Staci Vogel
Phone:
605-328-8000
Email:
Staci.Vogel@sanfordhealth.org
Investigator:
Last name:
Steven Powell
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030-4095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rabia Khan
Phone:
713-745-4667
Email:
RKhan@mdanderson.org
Investigator:
Last name:
Sarina A Piha-Paul
Email:
Principal Investigator
Facility:
Name:
Oncology Consultants, PA
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahran Shoukier
Email:
mshoukier@oncologyconsultants.com
Investigator:
Last name:
Mahran Shoukier
Email:
Principal Investigator
Facility:
Name:
Tranquil Clinical Research & Consulting Services, LLC
Address:
City:
Houston
Zip:
77598
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Hamilton
Phone:
713-907-6054
Email:
Jamesh@tranquilityresearch.com
Investigator:
Last name:
John Knecht, Knecht
Email:
Principal Investigator
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel Jimenez
Phone:
210-593-5265
Email:
isabel.jimenez@startsa.com
Investigator:
Last name:
Amita Patnaik
Email:
Principal Investigator
Facility:
Name:
UT Health East Texas Hope Cancer Center
Address:
City:
Tyler
Zip:
75701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Loredo
Phone:
903-592-6152
Email:
Grace.Loredo@uthct.edu
Investigator:
Last name:
Robert Droder
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Friedman
Email:
carrie.friedman@usoncology.com
Investigator:
Last name:
Alexander I Spira
Email:
Principal Investigator
Facility:
Name:
Vista Oncology Inc PS
Address:
City:
Olympia
Zip:
98506
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yiqun (Lydia) Xue
Phone:
360-810-3619
Email:
yiqun.xue@aoncology.com
Investigator:
Last name:
Joseph Z Ye
Email:
Principal Investigator
Facility:
Name:
Northwest Medical Specialties, PPLC
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sue Quinsey
Phone:
253-274-8473
Email:
squinsey@nwmsonline.com
Investigator:
Last name:
Jorge Chaves
Email:
Principal Investigator
Facility:
Name:
Center Hospitalier Universitaire d' Angers
Address:
City:
Angers Cedex 9
Zip:
49933
Country:
France
Status:
Recruiting
Investigator:
Last name:
Youssef Oulkhouir
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Investigator:
Last name:
Antoine Hollebecque
Email:
Principal Investigator
Facility:
Name:
Hospital HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Tatiana Carolina Hernandez Guerrero
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Omar Saavedra Santa Gadea, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Elena Garralda Cabanas
Email:
Principal Investigator
Facility:
Name:
Elche General University Hospital
Address:
City:
Elche
Zip:
03203
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alvaro Rodriguez Lescure
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario De Jerez
Address:
City:
Jerez de la Frontera
Zip:
11407
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jesus Corral
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Federico Longo
Email:
Principal Investigator
Facility:
Name:
START Madrid-CIOCC_Hospital HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Emiliano Calvo
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Fernando Rivera Herrero
Email:
Principal Investigator
Facility:
Name:
University Hospital Lausanne CHUV
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Investigator:
Last name:
Solange Peters
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute UK
Address:
City:
London
Zip:
W1G 6AD
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Elisa Fontana
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden Hospital (Surrey)
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Juanita Lopez
Email:
Principal Investigator
Start date:
June 8, 2020
Completion date:
February 28, 2028
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04389632
