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Looking for participantsPhase1

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

NCT ID: NCT06131840

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PF-08046050 (drug), bevacizumab (drug), 5-Fluorouracil (5-FU) (drug), Oxaliplatin (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
PF-08046050 — drug: Given into the vein (IV; intravenous) · bevacizumab — drug: Given into the vein (IV; intravenous) · 5-Fluorouracil (5-FU) — drug: Given into the vein (IV; intravenous) · Oxaliplatin — drug: Given into the vein (IV; intravenous) · Leucovorin (LV) — drug: Given into the vein (IV; intravenous)
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new experimental drug called SGN-CEACAM5C in adults with advanced solid tumours that have spread or cannot be removed by surgery. These include bowel (colorectal) cancer, non-small cell lung cancer, small cell lung cancer, stomach cancer, and pancreatic cancer. The study is run by Seagen, a wholly owned subsidiary of Pfizer.

Who can take part

  • Adults with advanced solid tumours that have spread or cannot be removed with surgery, and which have come back, not responded to treatment, or got worse, with no suitable standard treatment left (for some parts of the study)
  • People with bowel (colorectal) cancer who have had no more than 2 previous chemotherapy courses for advanced disease
  • People with pancreatic cancer who have had no more than 1 previous chemotherapy course for advanced disease and have spread that can be measured on scans
  • People with stomach cancer or gastro-oesophageal junction cancer who have had previous platinum and fluoropyrimidine chemotherapy
  • People with non-small cell lung cancer who have had platinum-based treatment, and immunotherapy (PD-1/PD-L1 inhibitor) if eligible and it is standard care
  • People with small cell lung cancer who have had platinum-based treatment for extensive-stage disease and no more than 3 previous lines of treatment
  • Some parts of the study need a tumour site that can be biopsied (a small sample taken), and agreement to biopsy or providing stored tissue samples
  • Being well enough for everyday activity (a performance status score of 0 or 1)
  • Having disease that can be measured on scans at the start of the study
  • Some participants take part in combination treatment with other cancer drugs (bevacizumab or chemotherapy drugs such as 5FU/LV and oxaliplatin) — extra rules apply, such as having had no previous treatment with drugs like irinotecan (a TOPO1 inhibitor) for certain groups

Who may not be able to

  • Previous treatment with any therapy that targets CEACAM5
  • Previous treatment with a TOPO1-targeting antibody-drug conjugate (CPT payload), such as trastuzumab deruxtecan (Enhertu) or sacituzumab govitecan (Trodelvy)
  • A history of another cancer within 3 years before the first dose of study treatment, or any sign of remaining disease from an earlier cancer
  • Active cancer in the brain or the linings of the brain and spinal cord (a past history is allowed if it was treated and the person is stable, with no steroid treatment for related symptoms for at least 2 weeks before joining)
  • For those receiving bevacizumab: allergic reactions to bevacizumab or its ingredients
  • Allergy to Chinese Hamster Ovary cell products or other similar man-made antibodies
  • A serious wound, ulcer, or bone fracture that is not healing
  • A blood clot in a deep vein within 4 weeks before joining
  • A known bleeding disorder or blood clotting problem that raises the risk of bleeding
  • A past life-threatening side effect related to drugs that block VEGF (a protein that helps tumours grow blood vessels)

What taking part involves

  • • SGN-CEACAM5C, an experimental study drug — how it works is not stated, ask the trial team
  • • In some parts of the study, SGN-CEACAM5C is given together with other cancer medicines: bevacizumab, 5FU/LV (a chemotherapy), or 5FU/LV plus oxaliplatin

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
914
Started
2023-11-20
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for colorectal neoplasms
  • • Phase1 - 914 participants
  • • This clinical trial is studying advanced solid tumors

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colorectal neoplasms

Where?

  • • London - The Harley Street Clinic (THSC)
  • • Edinburgh - Edinburgh Cancer Centre, Western General Hospital
  • • Edinburgh - Lothian Health Board
  • • Edinburgh - Western General Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Colorectal NeoplasmsCarcinoma, Non-Small-Cell LungStomach NeoplasmsPancreatic Ductal AdenocarcinomaGastroesophageal Junction AdenocarcinomaSmall Cell Lung Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1

Treatment history

Treatments you must have had:

  • ✓ histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy
  • ✓ one of the following tumor types: colorectal cancer (CRC)
  • ✓ received prior platinum and fluoropyrimidine-based chemotherapy
  • ✓ received platinum-based therapy

What the study is looking for

  • ✓Tumor type:
  • ✓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...
  • ✓GC or GEJ and must have received prior platinum and fluoropyrimidine-based drug treatment.
  • ✓Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and...

Who cannot take part

  • ✗Previous exposure to CEACAM5-treatment that targets specific changes in the cancer.
  • ✗Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy...
  • ✗History of another cancer within 3 years before the first dose of study intervention, or any evidence of...
  • ✗\> Criteria related to bevacizumab administration (participants in Parts D and E)
  • ✗History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
See the full criteria
Inclusion Criteria: 1. 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. * 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. 2. 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 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. Exclusion Criteria: 1. Previous exposure to CEACAM5-targeted therapy. 2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan). 3. 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. 4. 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) 5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients. 6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. 7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture. 8. Deep venous thromboembolic event within 4 weeks prior to enrollment 9. Known coagulopathy that increases risk of bleeding, bleeding diatheses. 10. History of any life-threatening VEGF-related adverse event

Where Is This Study? (8 UK sites)

The Harley Street Clinic (THSC)

London W1G 8BJ, United Kingdom

Recruiting

Edinburgh Cancer Centre, Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting

Lothian Health Board

Edinburgh EH3 9DN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Accord Office

enquiries@accord.scot0131 242 3330

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

Diagnostic Centre

London W1G 7AF, United Kingdom

Recruiting

The Harley Street Clinic

London W1G 7LJ, United Kingdom

Recruiting

Radiology

London W1G 8PP, United Kingdom

Recruiting

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07