A Study of PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
- Registration Number
- NCT06131840
- Lead Sponsor
- Seagen Inc.
- Brief 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 gotte...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 410
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Tumor type:
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Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Participants must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available at the time of enrollment in the judgement of the investigator. Participants in Part A must have one of the following tumor types:
- Colorectal cancer (CRC)
- Gastric carcinoma (GC) (including signet-ring cell histology) and gastroesophageal junction adenocarcinoma (GEJ)
- Non-small cell lung cancer (NSCLC), squamous or non-squamous histology
- 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 (dose escalation).
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Part C (dose expansion):
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Participants must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy.
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CRC
- Prior therapy: Participants must have received prior treatment (in 1 or more lines of therapy) containing fluoropyrimidine, oxaliplatin, and irinotecan.
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PDAC
- Prior therapy: Participants must have received 1 prior line of therapy and received no more than 3 prior lines of therapy in the advanced or metastatic setting.
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GC/GEJ
- Prior therapy: Participants must have received prior platinum and fluoropyrimidine-based chemotherapy.
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NSCLC - non-squamous/squamous
- Prior therapy: Participants 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.
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Small cell lung cancer (SCLC)
- Prior therapy: Participants 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.
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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
- Dose optimization
- Disease-specific expansion cohorts
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An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
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Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with an antibody-drug conjugate (ADC) with a camptothecin payload
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PF-08046050 PF-08046050 PF-08046050 monotherapy
- Primary Outcome Measures
Name Time Method Number of participants with DLTs by dose level Up to 28 days 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 dose modifications due to AEs Through end of treatment up to approximately 2 years Number of participants with laboratory abnormalities Through 30-37 days after the last study treatment, up to approximately 2 years Number of participants with dose-limiting toxicities (DLTs) Up to 28 days
- Secondary Outcome Measures
Name Time Method PK parameter - Maximum concentration (Cmax) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
PK parameter - Time to maximum concentration (Tmax) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
PK parameter - Trough concentration (Ctrough) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
Number of participants with antidrug antibodies (ADAs) Through 30-37 days after the last study treatment, up to approximately 2 years Objective response rate (ORR) Through end of study and up to approximately 2 years The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.
Best response Through end of study and up to approximately 2 years The best response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.
Duration of response (DOR) Through end of study and up to approximately 2 years DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause
Progression-free survival (PFS) Through end of study and up to approximately 2 years PFS is defined as the time from start of SGN-CEACAM5C to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first
Overall survival (OS) Through end of study and up to approximately 2 years OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause
Trial Locations
- Locations (20)
Netherlands Cancer Institute
🇳🇱Amsterdam, Other, Netherlands
Florida Cancer Specialists - Lake Nona
🇺🇸Orlando, Florida, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
University of Colorado Hospital / University of Colorado
🇺🇸Aurora, Colorado, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics Midwest
🇺🇸Grand Rapids, Michigan, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States
University of Ottawa / Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Other, Canada
Royal Victoria Hospital, McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
🇪🇸Barcelona, Other, Spain
START Madrid-CIOCC_Hospital HM Sanchinarro
🇪🇸Madrid, Other, Spain
Karolinska University Hospital
🇸🇪Stockholm, Other, Sweden
The University of Edinburgh
🇬🇧Edinburgh, Other, United Kingdom
Sarah Cannon Research Institute UK
🇬🇧London, Other, United Kingdom