Trial Title:
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
NCT ID:
NCT05571839
Condition:
Cutaneous Melanoma
Non-small Cell Lung Cancer
Colorectal Neoplasms
Pancreatic Neoplasms
Mesothelioma
Conditions: Official terms:
Neoplasms
Melanoma
Mesothelioma
Colorectal Neoplasms
Pancreatic Neoplasms
Conditions: Keywords:
NSCLC
Colorectal Cancer
CRC
Pancreatic Cancer
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:
PF-08046049
Description:
Given into the vein (IV; intravenous)
Arm group label:
PF-08046049
Summary:
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants
with melanoma and other solid tumors that are hard to treat or have spread through the
body. It will also study the side effects of this drug. A side effect is anything a drug
does to the body besides treating the disease.
This study will have 3 parts. Parts A and B of the study will find out how much
PF-08046049/SGN-BB228 should be given to participants. Part C will use the information
from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid
tumor cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All Parts: Participants must have disease that is relapsed, refractory, or
intolerant to standard of care. Participants must have histologically or
cytologically confirmed metastatic malignancy.
- Participants must have one of the following tumor types:
- Parts A and B: Participants must have metastatic or unresectable cutaneous
melanoma.
- Part C: Participants must have one of the following tumor types:
- Cutaneous Melanoma
- Non-small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Cancer
- Mesothelioma
- A pre-treatment biopsy or submission of archival tissue is required
- For participants with cutaneous melanoma
- Must have been previously treated with an anti-programmed death-1 (anti-PD-1)
or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other
therapies.
- Participants with a targetable BRAF mutation must have been treated with, been
intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK
targeted therapy prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:
- History of another malignancy within 3 years before the 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.
- Active central nervous system metastases or leptomeningeal disease. 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,
- they 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 the first dose of study drug.
- Prior therapies cannot include any drugs targeting CD228 or 4-1BB
- Immunotherapy, biologics, and/or other approved or investigational antitumor
treatment that is not completed 4 weeks prior to first dose of study drug, or within
2 weeks prior to the first dose of study drug if the underlying disease has
progressed on treatment
- Melanoma subtypes including acral, uveal, and mucosal are excluded
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mahesh Seetharam
Email:
Principal Investigator
Facility:
Name:
The Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Teresa Mata
Phone:
310-231-2115
Email:
tmata@theangelesclinic.org
Investigator:
Last name:
Omid Hamid
Email:
Principal Investigator
Facility:
Name:
University of California Los Angeles Medical Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Fady Bertan
Phone:
310-794-3879
Email:
FBertan@mednet.ucla.edu
Investigator:
Last name:
Antoni Ribas
Email:
Principal Investigator
Facility:
Name:
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Adil Daud, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute at HealthONE - Denver
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jason Henry
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ruqin Chen
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Werhawet Gebremeskel
Phone:
312-695-0387
Email:
werhawet.gebremeskel@northwestern.edu
Investigator:
Last name:
Sunandana Chandra
Email:
Principal Investigator
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Completed
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicholas Critch
Phone:
617-724-1268
Email:
ncritch@mgh.harvard.edu
Investigator:
Last name:
Kamaneh Montazeri
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Stephen Hodi
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Robert R McWilliams
Email:
Principal Investigator
Facility:
Name:
NYU Langone Hospital
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shirly Gholian
Phone:
212-731-6262
Investigator:
Last name:
Janice Mehnert
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Completed
Facility:
Name:
Texas Oncology - Baylor Sammons Cancer Center
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Charles Cowey
Email:
Principal Investigator
Facility:
Name:
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Viray
Phone:
206-606-7219
Email:
melrccreg@fredhutch.org
Investigator:
Last name:
Lisa Tachiki, MD
Email:
Principal Investigator
Facility:
Name:
Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Arif Ali Awan
Email:
Principal Investigator
Facility:
Name:
University Health Network, Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2C1
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Samuel Saibil
Email:
Principal Investigator
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Wilson H. Miller
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Investigator:
Last name:
Caroline Robert
Email:
Principal Investigator
Facility:
Name:
Charite Universitatsmedizin Berlin
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Thomas Eigentler
Email:
Principal Investigator
Facility:
Name:
Universitatsspital Zurich
Address:
City:
Zurich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Investigator:
Last name:
Reinhard Dummer
Email:
Principal Investigator
Facility:
Name:
NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0Yn
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Jeff Evans
Email:
Principal Investigator
Start date:
January 3, 2023
Completion date:
November 9, 2027
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/NCT05571839
