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Colorectal NeoplasmsPhase 1NCT06131840

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

A Phase 1 study testing PF-08046050, bevacizumab and 5-Fluorouracil (5-FU) in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 48 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046050, bevacizumab and 5-Fluorouracil (5-FU)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
914 participants
Where
48 sitesin 10 countries
Study dates
20 Nov 2023to 12 Sep 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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:
  • Monotherapy dose optimization (Part B)
  • Monotherapy (Part C) and combination therapy (Part E) 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

48 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

48 sites in 10 countries

United States21 sites, 21 recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Recruiting

  • Sidney Kimmel Comprehensive Cancer at Johns Hopkins

    Baltimore, Maryland, 21287

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

    Recruiting

  • IP Address: City of Hope Investigational Drug Services(IDS)

    Duarte, California, 91010

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • NEXT Dallas

    Irving, Texas, 75039

    Not yet recruiting

  • MidAmerica Cancer Care

    Kansas City, Missouri, 64132

    Not yet recruiting

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • START Mountain Region

    Salt Lake City, Utah, 84119

    Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85259

    Recruiting

  • South Texas Accelerated Research Therapeutics Mountain Region

    West Valley City, Utah, 84119

    Recruiting

Other trials in United States

United Kingdom8 sites, 8 recruiting

  • Edinburgh Cancer Centre, Western General Hospital

    Edinburgh, Scotland, EH4 2XU

    Recruiting

  • Lothian Health Board

    Edinburgh, EH3 9DN

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • The Harley Street Clinic (THSC)

    London, Other, W1G 8BJ

    Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

    Recruiting

  • Diagnostic Centre

    London, W1G 7AF

    Recruiting

  • The Harley Street Clinic

    London, W1G 7LJ

    Recruiting

  • Radiology

    London, W1G 8PP

    Recruiting

Other trials in United Kingdom

Spain5 sites, 5 recruiting

  • Ascires Cetir

    Barcelona, 08029

    Recruiting

  • Ascires CETIR

    Esplugues de Llobregat, 08950

    Recruiting

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908

    Recruiting

  • Servicio de Farmacia ICO - Planta 0

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

    Madrid, 28050

    Recruiting

Other trials in Spain

Canada4 sites, 4 recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2C4

    Recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

China3 sites, 3 recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Recruiting

  • Shandong First Medical University Cancer Hospital

    Jinan, Shandong, 250117

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 201321

    Not yet recruiting

Other trials in China

France2 sites, 2 recruiting

  • Institut Gustave Roussy

    Villejuif, Paris, 94805

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Sweden2 sites, 2 recruiting

  • Karolinska University Hospital

    Solna, 171 64

    Recruiting

  • ApoEx NKS

    Stockholm, 17176

    Recruiting

Other trials in Sweden

Israel1 site, 1 recruiting

  • Hadassah Medical Organization

    Jerusalem, 91120

    Not yet recruiting

Other trials in Israel

Japan1 site, 1 recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Recruiting

Other trials in Japan

Netherlands1 site, 1 recruiting

  • Netherlands Cancer Institute

    Amsterdam, 1066CX

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Being tested
PF-08046050, bevacizumab, 5-Fluorouracil (5-FU), Oxaliplatin, Leucovorin (LV)
Keywords
CRC, NSCLC, PDAC, GC, GEJ, SCLC, Seattle Genetics
Medical subject headings
Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046050Drug

    Also called SAR445953; SGN-CEACAM5C

    Given into the vein (IV; intravenous)

  • bevacizumabDrug

    Given into the vein (IV; intravenous)

  • 5-Fluorouracil (5-FU)Drug

    Given into the vein (IV; intravenous)

  • OxaliplatinDrug

    Given into the vein (IV; intravenous)

  • Leucovorin (LV)Drug

    Given into the vein (IV; intravenous)

Study groups in NCT06131840
Study groupRoleWhat they receive
PF-08046050ExperimentalPF-08046050 monotherapy
Receives: Drug: PF-08046050
PF-08046050 +bevacizumabExperimentalPF-08046050 combination with bevacizumab
Receives: Drug: PF-08046050; Drug: bevacizumab
PF-08046050 + bevacizumab + 5FU/LVExperimentalPF-08046050 combination with bevacizumab + 5FU/LV
Receives: Drug: PF-08046050; Drug: bevacizumab; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV)
PF-08046050 + 5FU/LV + oxaliplatin + bevacizumabExperimentalPF-08046050 combination with 5FU/LV + oxaliplatin + bevacizumab
Receives: Drug: PF-08046050; Drug: bevacizumab; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Leucovorin (LV)
PF-08046050 + 5FU/LV + oxaliplatinExperimentalPF-08046050 combination with 5FU/LV + oxaliplatin
Receives: Drug: PF-08046050; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Leucovorin (LV)
PF-08046050 + 5FU/LVExperimentalPF-08046050 combination with 5FU/LV
Receives: Drug: PF-08046050; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  2. Number of participants with laboratory abnormalities

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  3. Number of dose modifications due to AEs

    Measured: Through end of treatment up to approximately 2 years

  4. Number of participants with dose-limiting toxicities (DLTs)

    Measured: Up to 28 days

  5. Number of participants with DLTs by dose level

    Measured: Up to 28 days

Secondary outcomes (10)

  1. Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  2. PK parameter - Maximum concentration (Cmax)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  3. PK parameter - Time to maximum concentration (Tmax)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  4. PK parameter - Trough concentration (Ctrough)

    PK endpoint

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  5. Number of participants with antidrug antibodies (ADAs)

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  6. 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.

    Measured: Through end of study and up to approximately 2 years

  7. 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.

    Measured: Through end of study and up to approximately 2 years

  8. 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

    Measured: Through end of study and up to approximately 2 years

  9. 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

    Measured: Through end of study and up to approximately 2 years

  10. Overall survival (OS)

    OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause

    Measured: Through end of study and up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start20 Nov 2023
  3. Primary completion12 Sep 2029 (estimated)
  4. Study completion12 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
914 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131840
Sponsor's protocol ID
SGNCEA5C-001
Other IDs
C5831001, 2023-505858-18-00, 2023
Status last verified
Jul 2026
First submitted
9 Nov 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046050, bevacizumab and 5-Fluorouracil (5-FU) in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 48 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, United Kingdom, Spain, Canada, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Through 30-37 days after the last study treatment, up to approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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