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Clinical Trials in China / NCT06131840
Recruiting Phase 1

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

NCT06131840 · tracked via the Priya Life Science China tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 1
Started
2023-11-20
Last updated
2026-07-22

Condition(s) studied

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

Investigational drug(s) / intervention(s)

PF-08046050bevacizumab5-Fluorouracil (5-FU)OxaliplatinLeucovorin (LV)

PF-08046050: Given into the vein (IV; intravenous)

bevacizumab: Given into the vein (IV; intravenous)

5-Fluorouracil (5-FU): Given into the vein (IV; intravenous)

Oxaliplatin: Given into the vein (IV; intravenous)

Leucovorin (LV): Given into the vein (IV; intravenous)

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Recruiting
Mayo Clinic Scottsdale Arizona Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California Recruiting
IP Address: City of Hope Investigational Drug Services(IDS) Duarte California Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Aurora Colorado Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
Florida Cancer Specialists Orlando Florida Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists Orlando Florida Recruiting
Sidney Kimmel Comprehensive Cancer at Johns Hopkins Baltimore Maryland Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
START Midwest Grand Rapids Michigan Recruiting
Mayo Clinic Cancer Center Rochester Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
MidAmerica Cancer Care Kansas City Missouri Not Yet Recruiting
Sarah Cannon Research Institute - Pharmacy Nashville Tennessee Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Dallas Irving Texas Not Yet Recruiting
South Texas Accelerated Research Therapeutics, LLC San Antonio Texas Recruiting
START Mountain Region Salt Lake City Utah Recruiting
South Texas Accelerated Research Therapeutics Mountain Region West Valley City Utah Recruiting
The Ottawa Hospital Ottawa Ontario Recruiting
University Health Network Toronto Ontario Recruiting
University Health Network, Princess Margaret Cancer Centre Toronto Ontario Recruiting
McGill University Health Centre Montreal Quebec Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
Shandong First Medical University Cancer Hospital Jinan Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai China Not Yet Recruiting
Institut Gustave Roussy Villejuif Paris Recruiting
Gustave Roussy Villejuif France Recruiting
Hadassah Medical Organization Jerusalem Israel Not Yet Recruiting
National Cancer Center Hospital East Kashiwa Chiba Recruiting
Netherlands Cancer Institute Amsterdam Netherlands Recruiting
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet) L'Hospitalet de Llobregat Catalunya [cataluña] Recruiting
Ascires Cetir Barcelona Spain Recruiting
Ascires CETIR Esplugues de Llobregat Spain Recruiting
Servicio de Farmacia ICO - Planta 0 L'Hospitalet de Llobregat Spain Recruiting
Hospital Universitario HM Sanchinarro-CIOCC-START Madrid Madrid Spain Recruiting
Karolinska University Hospital Solna Sweden Recruiting
ApoEx NKS Stockholm Sweden Recruiting

+ 8 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile →

More Seagen, a wholly owned subsidiary of Pfizer trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06131840 on ClinicalTrials.gov ↗ ← All trials in China