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

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Colorectal Neoplasms; Pancreatic Ductal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: PF-08046050; Drug: bevacizumab; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV); Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 914
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • University Health Network
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network, Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Not yet recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
• France
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
  • Paris
    • Villejuif, Paris, France, 94805
      • Recruiting
      • Institut Gustave Roussy
• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • Netherlands Cancer Institute
• Spain
  • Barcelona, Spain, 08029
    • Recruiting
    • Ascires CETIR
  • Esplugues de Llobregat, Spain, 08950
    • Recruiting
    • Ascires CETIR
  • L'Hospitalet de Llobregat, Spain, 08908
    • Recruiting
    • Servicio de Farmacia ICO - Planta 0
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
  • Catalunya [cataluña]
    • L'Hospitalet de Llobregat, Catalunya [cataluña], Spain, 08908
      • Recruiting
      • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
• Sweden
  • Solna, Sweden, 171 64
    • Recruiting
    • Karolinska University Hospital
  • Stockholm, Sweden, 17176
    • Recruiting
    • ApoEx NKS
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Western General Hospital
  • Edinburgh, United Kingdom, EH3 9DN
    • Recruiting
    • Lothian Health Board
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute UK
  • London, United Kingdom, W1G 8PP
    • Recruiting
    • Radiology
  • London, United Kingdom, W1G 7LJ
    • Recruiting
    • The Harley Street Clinic
  • Other
    • London, Other, United Kingdom, W1G 8BJ
      • Recruiting
      • The Harley Street Clinic (THSC)
  • Others
    • London, Others, United Kingdom, WlG 7AF
      • Recruiting
      • Diagnostic Centre
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH4 2XU
      • Recruiting
      • Edinburgh Cancer Centre, Western General Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    • Duarte, California, United States, 91010
      • Recruiting
      • IP Address: City of Hope Investigational Drug Services(IDS)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Sarah Cannon Research Institute at Florida Cancer Specialists
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Florida Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • The Johns Hopkins University
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Sidney Kimmel Comprehensive Cancer At Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Andrea Bullock
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute - Pharmacy
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84119
      • Recruiting
      • START Mountain Region
    • West Valley City, Utah, United States, 84119
      • Recruiting
      • South Texas Accelerated Research Therapeutics Mountain Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.

2. 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:

   • Monotherapy dose optimization (Part B)
   • Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts
3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.

Exclusion Criteria:

1. Previous exposure to CEACAM5-targeted therapy.
2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
3. 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.

4. 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)

5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.
8. Deep venous thromboembolic event within 4 weeks prior to enrollment
9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.
10. History of any life-threatening VEGF-related adverse event

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08046050; PF-08046050 monotherapy	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C
Experimental: PF-08046050 +bevacizumab; PF-08046050 combination with bevacizumab	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C; Drug: bevacizumab; Given into the vein (IV; intravenous)
Experimental: PF-08046050 + bevacizumab + 5FU/LV; PF-08046050 combination with bevacizumab + 5FU/LV	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C; Drug: bevacizumab; Given into the vein (IV; intravenous); Drug: 5-Fluorouracil (5-FU); Given into the vein (IV; intravenous); Drug: Leucovorin (LV); Given into the vein (IV; intravenous)
Experimental: PF-08046050 + 5FU/LV + oxaliplatin + bevacizumab; PF-08046050 combination with 5FU/LV + oxaliplatin + bevacizumab	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C; Drug: bevacizumab; Given into the vein (IV; intravenous); Drug: 5-Fluorouracil (5-FU); Given into the vein (IV; intravenous); Drug: Leucovorin (LV); Given into the vein (IV; intravenous); Drug: Oxaliplatin; Given into the vein (IV; intravenous)
Experimental: PF-08046050 + 5FU/LV + oxaliplatin; PF-08046050 combination with 5FU/LV + oxaliplatin	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C; Drug: 5-Fluorouracil (5-FU); Given into the vein (IV; intravenous); Drug: Leucovorin (LV); Given into the vein (IV; intravenous); Drug: Oxaliplatin; Given into the vein (IV; intravenous)
Experimental: PF-08046050 + 5FU/LV; PF-08046050 combination with 5FU/LV	Drug: PF-08046050; Given into the vein (IV; intravenous); Other Names: SAR445953; SGN-CEACAM5C; Drug: 5-Fluorouracil (5-FU); Given into the vein (IV; intravenous); Drug: Leucovorin (LV); Given into the vein (IV; intravenous)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with dose-limiting toxicities (DLTs)		Up to 28 days
Number of participants with DLTs by dose level		Up to 28 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)	PK endpoint	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
Objective response rate (ORR)	The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.	Through end of study and up to approximately 2 years
Duration of response (DOR)	DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause	Through end of study and up to approximately 2 years
Progression-free survival (PFS)	PFS is defined as the time from start of SGN-CEACAM5C to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first	Through end of study and up to approximately 2 years
Overall survival (OS)	OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause	Through end of study and up to approximately 2 years
Best overall response	The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.	Through end of study and up to approximately 2 years

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Collaborators: Sanofi
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): September 12, 2029
• Study Completion (Estimated): September 12, 2030

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Seattle Genetics; CRC; SCLC; PDAC; GEJ; GC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Oxaliplatin; Bevacizumab; Fluorouracil; Leucovorin
• Other Study ID Numbers: SGNCEA5C-001; C5831001 (Other Identifier: Alias Study Number); 2023-505858-18-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No