A Study of SGN-CEACAM5C for Advanced Solid Tumors
This study is for adults with advanced solid tumors, including certain types of colorectal, lung, stomach, pancreatic, and gastroesophageal junction cancers. These are cancers that have spread or cannot be removed by surgery, and have not responded to standard treatments. The study is testing a drug called PF-08046050, sometimes given with other drugs like bevacizumab, 5-Fluorouracil (5-FU), Oxaliplatin, and Leucovorin (LV). Researchers are looking at how many participants experience side effects or changes in lab tests, and how often drug doses need to be adjusted. The study aims to enroll 914 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 914 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events and laboratory abnormalities for up to approximately 2 years after their last study treatment.
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NCT06131840
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentSeagen, a wholly owned subsidiary of Pfizer
~914 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-08046050bevacizumab5-Fluorouracil (5-FU)OxaliplatinLeucovorin (LV)
At a glance
Recruiting sites
43 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Through 30-37 days after the last study treatment, up to approximately 2 years
+4 more outcomes measured
Conditions
Where it's being run
48 sites across 28 statesUnited Kingdom6
Spain4
Texas3
Ontario3
Arizona2
California2
Colorado2
Florida2
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Monotherapy dose optimization (Part B)
Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts 3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.
What this trial measures
- Number of participants with adverse events (AEs)Through 30-37 days after the last study treatment, up to approximately 2 years
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
- Number of participants with laboratory abnormalitiesThrough 30-37 days after the last study treatment, up to approximately 2 years
- Number of dose modifications due to AEsThrough end of treatment up to approximately 2 years
- Number of participants with dose-limiting toxicities (DLTs)Up to 28 days
- Number of participants with DLTs by dose levelUp to 28 days