*Colorectal Neoplasms *Carcinoma, Non-Small-Cell Lung *Stomach Neoplasms *3 more
Conditions
Interventions
*Drug: PF-08046050
-Given into the vein (IV
intravenous)
-Other Names:
#SAR445953
SGN-CEACAM5C
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Tumor type: -Participants 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 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). 2. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 3. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Number of participants with adverse events (AEs) [Time Frame: 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 participants with laboratory abnormalities [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *Number of dose modifications due to AEs [Time Frame: Through end of treatment up to approximately 2 years] *Number of participants with dose-limiting toxicities (DLTs) [Time Frame: Up to 28 days] *Number of participants with DLTs by dose level [Time Frame: Up to 28 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| *Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *PK parameter - Maximum concentration (Cmax) [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *PK parameter - Time to maximum concentration (Tmax) [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *PK parameter - Trough concentration (Ctrough) [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *Number of participants with antidrug antibodies (ADAs) [Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years] *Objective response rate (ORR) [Time Frame: 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 overall response [Time Frame: Through end of study and up to approximately 2 years] -The best overall 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) [Time Frame: 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) [Time Frame: 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 surviva | — |
Countries
Canada, France, Japan, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed