Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
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
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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