Trial Title:
A Study of PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
NCT ID:
NCT06131840
Condition:
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Pancreatic Ductal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Small Cell Lung Carcinoma
Conditions: Official terms:
Carcinoma
Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
CRC
NSCLC
PDAC
GC
GEJ
SCLC
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:
PF-08046050
Description:
Given into the vein (IV; intravenous)
Arm group label:
PF-08046050
Other name:
SAR445953; SGN-CEACAM5C
Summary:
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that
start in a part of your body like your lungs or liver instead of your blood. Once tumors
have grown bigger in one place but haven't spread, they're called locally advanced. If
your cancer has spread to other parts of your body, it's called metastatic. When a cancer
has gotten so big it can't easily be removed or has spread to other parts of the body, it
is called unresectable. These types of cancer are harder to treat.
Patients in this study must have cancer that has come back or did not get better with
treatment. Patients must have a solid tumor cancer that can't be treated with standard of
care drugs.
This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type
of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. They may also stick to some normal cells.
This study will test the safety of PF-08046050 in participants with solid tumors that are
hard to treat or have spread throughout the body.
This study will have 3 parts. Part A and Part B of the study will find out how much
PF-08046050 should be given to participants. Part C will use the information from Parts A
and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Tumor type:
1. Participants in Part A (dose escalation) and Part B (dose optimization) must
have histologically- or cytologically-confirmed metastatic or unresectable
solid tumor malignancy. Participants must have relapsed, refractory, or
progressive disease, and should have no appropriate standard therapy available
at the time of enrollment in the judgement of the investigator. Participants in
Part A must have one of the following tumor types:
- Colorectal cancer (CRC)
- Gastric carcinoma (GC) (including signet-ring cell histology) and
gastroesophageal junction adenocarcinoma (GEJ)
- Non-small cell lung cancer (NSCLC), squamous or non-squamous histology
- Pancreatic ductal adenocarcinoma (PDAC)
- The tumor types to be enrolled in Part B will be identified by the sponsor
from among those specified in Part A (dose escalation).
2. Part C (dose expansion):
- Participants must have histologically- or cytologically-confirmed
metastatic or unresectable solid tumor malignancy.
- CRC
- Prior therapy: Participants must have received prior treatment (in 1
or more lines of therapy) containing fluoropyrimidine, oxaliplatin,
and irinotecan.
- PDAC
- Prior therapy: Participants must have received 1 prior line of
therapy and received no more than 3 prior lines of therapy in the
advanced or metastatic setting.
- GC/GEJ
- Prior therapy: Participants must have received prior platinum and
fluoropyrimidine-based chemotherapy.
- NSCLC - non-squamous/squamous
- Prior therapy: Participants must have received platinum-based
therapy. If eligible and consistent with local standard of care must
have received a PD-1/PD-L1 inhibitor.
- In addition, Participants with tumor genomic mutations/alterations
for which approved targeted therapies are available per local
standard of care, must have received such therapies.
- Small cell lung cancer (SCLC)
- Prior therapy: Participants must have received platinum-based therapy
for extensive-stage disease and no more than 3 prior lines of
therapy. If eligible and consistent with local standard of care must
have received a PD 1/PD-L1 inhibitor.
- Participants enrolled in the following study parts should have a tumor site that is
accessible for biopsy(ies) and agree to biopsy(ies) and/or submission of archival
tissue
1. Dose optimization
2. Disease-specific expansion cohorts
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at
baseline.
Exclusion Criteria:
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with an antibody-drug conjugate (ADC) with a camptothecin payload
- History of another malignancy within 3 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy.
- Active cerebral/meningeal disease related to the underlying malignancy. Participants
with a history of cerebral/meningeal disease related to the underlying malignancy
are allowed if prior central nervous system disease has been treated and the
participant is clinically stable (defined as not having received steroid treatment
for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to
enrollment and with no ongoing related AEs).
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:
Mitesh Borad
Email:
Principal Investigator
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Olson
Email:
jolson@coh.org
Investigator:
Last name:
Marwan G Fakih
Email:
Principal Investigator
Facility:
Name:
University of Colorado Hospital / University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Daniels
Phone:
303-724-9848
Email:
KATHERINE.M.DANIELS@CUANSCHUTZ.EDU
Investigator:
Last name:
Sarah L Davis
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:
Johns Hopkins Medical Center
Address:
City:
Baltimore
Zip:
21224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Wendler
Phone:
410-502-5140
Email:
JHCTN@jhmi.edu
Investigator:
Last name:
Nilofer S Azad
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrea Bullock
Email:
Principal Investigator
Facility:
Name:
South Texas Accelerated Research Therapeutics Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Nehal Lakhani, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Cannon Research Institute General Inquiry Inbox
Phone:
844-482-4812
Email:
asksarah@SCRI.com
Investigator:
Last name:
Meredith Sellers Pelster
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anjali Raina
Phone:
713-792-3238
Email:
ARaina@mdanderson.org
Investigator:
Last name:
Funda Meric-Bernstam
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:
210-593-5259
Email:
isabel.jimenez@startsa.com
Investigator:
Last name:
Amita Patnaik
Email:
Principal Investigator
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Asay
Phone:
801-907-4770
Email:
marie.asay@startthecure.com
Investigator:
Last name:
Justin Call
Email:
Principal Investigator
Facility:
Name:
University of Ottawa / Ottawa General Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Derek Jonker
Email:
Principal Investigator
Facility:
Name:
University Health Network, Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2C1
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Philippe Bedard
Email:
Principal Investigator
Facility:
Name:
Royal Victoria Hospital, McGill University Health Centre
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Victoria Mandilaras
Email:
Principal Investigator
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066 WX
Country:
Netherlands
Status:
Recruiting
Investigator:
Last name:
Neeltje Steeghs
Email:
Principal Investigator
Facility:
Name:
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Marc Oliva
Email:
Principal Investigator
Facility:
Name:
START Madrid-CIOCC_Hospital HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Irene Moreno Candilejo
Email:
Principal Investigator
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Investigator:
Last name:
Luigi De Petris
Email:
Principal Investigator
Facility:
Name:
The University of Edinburgh
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Stefan Symeonides
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
Start date:
November 20, 2023
Completion date:
March 31, 2030
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Collaborator:
Agency:
Sanofi
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/NCT06131840
