Taking people in NetherlandsPhase 1

Tests PF-08046050 in adults with advanced solid tumors

Tests an experimental antibody-drug conjugate in adults with hard-to-treat solid tumors.

Plain-language title generated from the registry record
Registry title: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

Key facts

Where: Amsterdam and Groningen, NetherlandsSee the 3 sites
Phase: Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors (colorectal, stomach or gastroesophageal junction, lung, or pancreatic cancer) that have spread or cannot be removed by surgery. It tests the experimental drug PF-08046050, alone or with other cancer drugs.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Metastatic or unresectable solid tumor (colorectal, gastric or gastroesophageal junction, non-small cell lung, small cell lung, or pancreatic ductal cancer) that came back, did not respond or got worse. Measurable disease and ECOG performance status 0 or 1.
Earlier treatment: Depending on the study part, no standard therapy available, or a set number of earlier treatments (for example, no more than 2 chemotherapy regimens for colorectal cancer). In some parts, no earlier irinotecan-type (TOPO1 inhibitor) drug. Cannot have had CEACAM5-targeted therapy or a TOPO1-targeting ADC such as Enhertu or Trodelvy.

Main reasons for not taking part

Earlier CEACAM5-targeted therapy
Earlier treatment with a TOPO1-targeting ADC such as Enhertu or Trodelvy
Another cancer within 3 years before the first dose
Active brain or meninges disease from the cancer
For parts with bevacizumab: allergy to bevacizumab, non-healing wound, or a deep vein blood clot within 4 weeks

Read by machine on 9 November 2026.

Where in Netherlands

Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: Seagen, a wholly owned subsidiary of Pfizer
Trial code: NCT06131840 EU 2023-505858-18-00
Record updated: 22 July 2026
Original description: 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.Read full original descriptionShow less
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.
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.
Inclusion: 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; 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.
Exclusion: Previous exposure to CEACAM5-targeted therapy; Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan); 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); Deep venous thromboembolic event within 4 weeks prior to enrollment; 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; History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients; 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; Known coagulopathy that increases risk of bleeding, bleeding diatheses; History of any life-threatening VEGF-related adverse event.
ClinicalTrials.gov NCT06131840 · EU CTIS 2023-505858-18-00