A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
3 other identifiers
interventional
914
8 countries
44
Brief 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. Participants in this study must have cancer that has come back or did not get better with treatment. Participants 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 has 5 different study 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. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2023
Longer than P75 for phase_1
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 14, 2023
CompletedStudy Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 12, 2030
April 20, 2026
April 1, 2026
5.8 years
November 9, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Up to 28 days
Number of participants with DLTs by dose level
Up to 28 days
Secondary Outcomes (10)
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Through 30-37 days after the last study treatment, up to approximately 2 years
- +5 more secondary outcomes
Study Arms (6)
PF-08046050
EXPERIMENTALPF-08046050 monotherapy
PF-08046050 +bevacizumab
EXPERIMENTALPF-08046050 combination with bevacizumab
PF-08046050 + bevacizumab + 5FU/LV
EXPERIMENTALPF-08046050 combination with bevacizumab + 5FU/LV
PF-08046050 + 5FU/LV + oxaliplatin + bevacizumab
EXPERIMENTALPF-08046050 combination with 5FU/LV + oxaliplatin + bevacizumab
PF-08046050 + 5FU/LV + oxaliplatin
EXPERIMENTALPF-08046050 combination with 5FU/LV + oxaliplatin
PF-08046050 + 5FU/LV
EXPERIMENTALPF-08046050 combination with 5FU/LV
Interventions
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Eligibility Criteria
You may qualify if:
- Tumor type:
- Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.
- Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or 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.
- Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.
- CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.
- PDAC with one or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.
- GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.
- NSCLC and 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) and 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.
- CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
- CRC participants in Part D and Part E (5FU/LV + bevacizumab and 5FU/LV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU/LV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.
- \> 2L PDAC participants in Part E (5FU/LV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
- \> 1L PDAC participants in Part E (5FU/LV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant/neoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant/neoadjuvant chemotherapy are eligible.
- 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:
- +4 more criteria
You may not qualify if:
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
- 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).
- \> Criteria related to bevacizumab administration (participants in Parts D and E)
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.
- Deep venous thromboembolic event within 4 weeks prior to enrollment
- Known coagulopathy that increases risk of bleeding, bleeding diatheses.
- History of any life-threatening VEGF-related adverse event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen, a wholly owned subsidiary of Pfizerlead
- Sanoficollaborator
Study Sites (44)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, 91010, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Florida Cancer Specialists
Orlando, Florida, 32827, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827, United States
Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, Maryland, 21287, United States
The Johns Hopkins University
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
START Mountain Region
Salt Lake City, Utah, 84119, United States
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City, Utah, 84119, United States
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Institut Gustave Roussy
Villejuif, Paris, 94805, France
Gustave Roussy
Villejuif, 94800, France
Netherlands Cancer Institute
Amsterdam, 1066CX, Netherlands
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain
Ascires Cetir
Barcelona, 08029, Spain
Ascires CETIR
Esplugues de Llobregat, 08950, Spain
Servicio de Farmacia ICO - Planta 0
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
Madrid, 28050, Spain
Karolinska University Hospital
Solna, 171 64, Sweden
ApoEx NKS
Stockholm, 17176, Sweden
Diagnostic Centre
London, Others, WlG 7AF, United Kingdom
The Harley Street Clinic (THSC)
London, Other, W1G 8BJ, United Kingdom
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Lothian Health Board
Edinburgh, EH3 9DN, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
The Harley Street Clinic
London, W1G 7LJ, United Kingdom
Radiology
London, W1G 8PP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 14, 2023
Study Start
November 20, 2023
Primary Completion (Estimated)
September 12, 2029
Study Completion (Estimated)
September 12, 2030
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.