Actively Recruiting
An Open-label Phase 1 Study to Investigate PF-08046050 (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
52 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
Researchers are studying advanced solid tumors, which are cancers that start in organs like the lungs or liver instead of the blood. The focus is on tumors that are locally advanced, metastatic, or unresectable, meaning they have grown large or spread and are difficult to treat. This trial evaluates an experimental drug called PF-08046050, an antibody-drug conjugate designed to target and kill cancer cells, in patients with solid tumors that have returned or not responded to standard treatments. The study has five parts to find the right dose and assess safety and effectiveness of PF-08046050 alone and in combination with other cancer drugs like bevacizumab, 5-Fluorouracil (5-FU), leucovorin, and oxaliplatin. Treatments are given intravenously and combinations vary by study group, including monotherapy and various drug combinations. Earlier parts focus on dose-finding, while later parts evaluate the drug’s safety and potential effects on specific tumor types. Participants will undergo biopsies if accessible and regular assessments including imaging scans to measure tumor response, laboratory tests to monitor safety and drug levels, and tracking for side effects and dose adjustments. Key outcomes measured include adverse events, dose-limiting toxicities, pharmacokinetics, tumor response rates, progression-free survival, and overall survival. The study may last up to about two years after the last treatment to track these effects and monitor safety.
CONDITIONS
Brief Title
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with confirmed metastatic or unresectable solid tumor malignancies.
- Participants in Parts A and B must have relapsed, refractory, or progressive colorectal cancer, gastric carcinoma, gastroesophageal junction adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma without appropriate standard therapy.
- Participants in Part C must have specific solid tumors including colorectal, pancreatic, gastric/gastroesophageal, non-small cell lung, or small cell lung cancers with prior specified treatments.
- Participants in Parts D and E must have histologically confirmed unresectable or metastatic colorectal or pancreatic cancers with defined prior chemotherapy regimens.
- Agree to tumor biopsies or submit archival tissue when accessible for specified study parts.
- ECOG Performance Status score of 0 or 1.
- Measurable disease per RECIST v1.1 at baseline.
You will not qualify if you...
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with topoisomerase 1-targeting antibody-drug conjugates.
- History of another malignancy within 3 years or residual disease from previous cancers.
- Active brain or meningeal disease related to cancer unless stable and off steroids for 2 weeks.
- Allergic reactions or hypersensitivity to bevacizumab or similar antibodies.
- Serious non-healing wounds, ulcers, or bone fractures.
- Recent deep vein thrombosis within 4 weeks.
- Known bleeding disorders or life-threatening VEGF-related adverse events.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive PF-08046050 alone or in combination with other intravenous drugs as part of their cancer treatment.
Repeated treatment cycles with intravenous infusions according to assigned regimen
Duration - 30 to 37 days after the last study treatment, up to approximately 2 years
Participants are monitored for safety, adverse events, and treatment outcomes after completing treatment.
Regular visits for safety and efficacy assessments
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
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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