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.
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
- Conditions the study is for
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
- 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
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.
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- 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.
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- 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.
48 sites in 10 countries
United States21 sites, 21 recruiting
- 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
- Not yet recruiting
NEXT Dallas
Irving, Texas, 75039
- Not yet recruiting
MidAmerica Cancer Care
Kansas City, Missouri, 64132
- 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
United Kingdom8 sites, 8 recruiting
- 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
Spain5 sites, 5 recruiting
- 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
Canada4 sites, 4 recruiting
- 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
China3 sites, 3 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Not yet recruiting
Shandong First Medical University Cancer Hospital
Jinan, Shandong, 250117
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 201321
France2 sites, 2 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, Paris, 94805
- Recruiting
Gustave Roussy
Villejuif, 94800
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital
Solna, 171 64
- Recruiting
ApoEx NKS
Stockholm, 17176
Israel1 site, 1 recruiting
- Not yet recruiting
Hadassah Medical Organization
Jerusalem, 91120
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, 1066CX
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.
- Conditions
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Pancreatic Ductal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Small Cell Lung Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| PF-08046050 | Experimental | PF-08046050 monotherapy Receives: Drug: PF-08046050 |
| PF-08046050 +bevacizumab | Experimental | PF-08046050 combination with bevacizumab Receives: Drug: PF-08046050; Drug: bevacizumab |
| PF-08046050 + bevacizumab + 5FU/LV | Experimental | PF-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 + bevacizumab | Experimental | PF-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 + oxaliplatin | Experimental | PF-08046050 combination with 5FU/LV + oxaliplatin Receives: Drug: PF-08046050; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Leucovorin (LV) |
| PF-08046050 + 5FU/LV | Experimental | PF-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.
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
Number of participants with laboratory abnormalities
Measured: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Measured: Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Number of participants with DLTs by dose level
Measured: Up to 28 days
Secondary outcomes (10)
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
PK parameter - Maximum concentration (Cmax)
PK endpoint
Measured: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
Measured: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
PK endpoint
Measured: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
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.
- First posted14 Nov 2023
- Study start20 Nov 2023
- Primary completion12 Sep 2029 (estimated)
- Study completion12 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
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.