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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (8 UK sites)
The Harley Street Clinic (THSC)
London W1G 8BJ, United Kingdom
Edinburgh Cancer Centre, Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Lothian Health Board
Edinburgh EH3 9DN, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Sarah Cannon Research Institute UK
London W1G 6AD, United Kingdom
Diagnostic Centre
London W1G 7AF, United Kingdom
The Harley Street Clinic
London W1G 7LJ, United Kingdom
Radiology
London W1G 8PP, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
