Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06131840

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

Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-04-20

914

Participants Needed

44

Research Sites

355 weeks

Total Duration

On this page

Sponsors

S

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

S

Sanofi

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a histologically or cytologically confirmed metastatic or unresectable solid tumor malignancy that is relapsed, refractory, or progressive with no standard therapy available
  • For Parts A and B, have colorectal cancer, gastric or gastroesophageal junction carcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma
  • For Part C, have specific tumor types including colorectal cancer with no more than 2 prior chemotherapy regimens, pancreatic ductal adenocarcinoma with no more than 1 prior chemotherapy regimen, gastric or gastroesophageal junction cancer with prior platinum and fluoropyrimidine chemotherapy, non-small cell lung cancer with prior platinum-based therapy and possibly PD-1/PD-L1 inhibitor, or small cell lung cancer with prior platinum-based therapy and up to 3 prior lines of therapy
  • For Parts D and E, colorectal cancer participants must have unresectable or metastatic adenocarcinoma with limited prior chemotherapy exposure and no prior TOPO1 inhibitors
  • For Part E pancreatic ductal adenocarcinoma participants, must have measurable metastatic lesions and specific prior treatment histories
  • Have tumor sites accessible for biopsy for certain study parts
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Have measurable disease per RECIST v1.1 criteria at baseline
Not Eligible

You will not qualify if you...

  • Prior exposure to CEACAM5-targeted therapy
  • Prior treatment with TOPO1-targeting antibody-drug conjugates such as Enhertu or Trodelvy
  • History of another cancer within 3 years or residual disease from previous malignancy
  • Active brain or meningeal disease related to cancer unless treated and stable
  • Allergic reactions or hypersensitivity to bevacizumab or its components
  • Hypersensitivity to Chinese Hamster Ovary cell products or similar antibodies
  • Serious non-healing wounds, ulcers, or bone fractures
  • Deep venous thromboembolism within 4 weeks before enrollment
  • Known bleeding disorders or coagulopathy
  • History of life-threatening VEGF-related adverse events

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 44 locations

1

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Mayo Clinic

Scottsdale, Arizona, United States, 85259

Actively Recruiting

3

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

Duarte, California, United States, 91010

Actively Recruiting

4

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

Duarte, California, United States, 91010

Actively Recruiting

5

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Actively Recruiting

6

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

7

Florida Cancer Specialists

Orlando, Florida, United States, 32827

Actively Recruiting

8

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States, 32827

Actively Recruiting

9

Sidney Kimmel Comprehensive Cancer at Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

10

The Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

11

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

Actively Recruiting

12

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

13

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

14

Mayo Clinic Cancer Center

Rochester, Minnesota, United States, 55905

Actively Recruiting

15

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

16

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, United States, 37203

Actively Recruiting

17

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

18

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

19

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

Actively Recruiting

20

START Mountain Region

Salt Lake City, Utah, United States, 84119

Actively Recruiting

21

South Texas Accelerated Research Therapeutics Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

22

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

23

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

24

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

25

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

26

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Not Yet Recruiting

27

Institut Gustave Roussy

Villejuif, Paris, France, 94805

Actively Recruiting

28

Gustave Roussy

Villejuif, France, 94800

Actively Recruiting

29

Netherlands Cancer Institute

Amsterdam, Netherlands, 1066CX

Actively Recruiting

30

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

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

Actively Recruiting

31

Ascires Cetir

Barcelona, Spain, 08029

Actively Recruiting

32

Ascires CETIR

Esplugues de Llobregat, Spain, 08950

Actively Recruiting

33

Servicio de Farmacia ICO - Planta 0

L'Hospitalet de Llobregat, Spain, 08908

Actively Recruiting

34

Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

Madrid, Spain, 28050

Actively Recruiting

35

Karolinska University Hospital

Solna, Sweden, 171 64

Actively Recruiting

36

ApoEx NKS

Stockholm, Sweden, 17176

Actively Recruiting

37

Diagnostic Centre

London, Others, United Kingdom, WlG 7AF

Actively Recruiting

38

The Harley Street Clinic (THSC)

London, Other, United Kingdom, W1G 8BJ

Actively Recruiting

39

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, Scotland, United Kingdom, EH4 2XU

Actively Recruiting

40

Lothian Health Board

Edinburgh, United Kingdom, EH3 9DN

Actively Recruiting

41

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Actively Recruiting

42

Sarah Cannon Research Institute UK

London, United Kingdom, W1G 6AD

Actively Recruiting

43

The Harley Street Clinic

London, United Kingdom, W1G 7LJ

Actively Recruiting

44

Radiology

London, United Kingdom, W1G 8PP

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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