The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Clinical Trial Details
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CEACAM5-directed Antibody Drug Conjugate
PF-08046050, SGN-CEACAM5C is an investigational compound. Its safety and efficacy have not been established.
An Open-label Phase 1 Study to Investigate SGN-CEACAM5C in Adults With Advanced Solid Tumors
Phase 1
NCT06131840
Active enrolling
Locations
United States, Canada
Study design
Participant Group/Arm
EXPERIMENTAL: SGN-CEACAM5C
SGN-CEACAM5C monotherapy
Intervention/Treatment
DRUG: SGN-CEACAM5C
Given into the vein (IV; intravenous)
Key eligibility criteria
Inclusion criteria
- Tumor type:
- Participants in Part A (dose escalation) 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 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)
- For Part B (dose optimization) and Part C (dose expansion):
- Participants must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy.
- The tumor types to be enrolled in dose optimization will be identified by the sponsor from among those specified in dose escalation.
- CRC
- Prior therapy: Participants must have received prior treatment (in 1 or more lines of therapy) containing fluoropyrimidine, oxaliplatin, and irinotecan.
- 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.
- GC/GEJ
- Prior therapy: Participants must have received prior platinum and fluoropyrimidine-based chemotherapy.
- 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.
- 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
- Participants in Part A (dose escalation) 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 must have one of the following tumor types:
- 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
- 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 criteria
- 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).
Key dates
Study start date
- November 2023
Estimated primary completion date
- March 2030
Key endpoints
Primary Outcome Measures
Outcome Measure
Number of participants with adverse events (AEs)
Measure Description
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
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
Number of participants with laboratory abnormalities
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
Number of dose modifications due to AEs
Time Frame
Through end of treatment up to approximately 2 years
Outcome Measure
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
Up to 28 days
Outcome Measure
Number of participants with DLTs by dose level
Time Frame
Up to 28 days
Secondary Outcome Measures:
Outcome Measure
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Measure Description
PK endpoint
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
PK parameter - Maximum concentration (Cmax)
Measure Description
PK endpoint
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
PK parameter - Time to maximum concentration (Tmax)
Measure Description
PK endpoint
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
PK parameter - Trough concentration (Ctrough)
Measure Description
PK endpoint
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
Number of participants with antidrug antibodies (ADAs)
Time Frame
Through 30-37 days after the last study treatment, up to approximately 2 years
Outcome Measure
Objective response rate (ORR)
Measure Description
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.
Time Frame
Through end of study and up to approximately 2 years
Outcome Measure
Best response
Measure Description
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.
Time Frame
Through end of study and up to approximately 2 years
Outcome Measure
Duration of response (DOR)
Measure Description
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
Time Frame
Through end of study and up to approximately 2 years
Outcome Measure
Progression-free survival (PFS)
Measure Description
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
Time Frame
Through end of study and up to approximately 2 years
Outcome Measure
Overall survival (OS)
Measure Description
OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause
Time Frame
Through end of study and up to approximately 2 years
Number of participants
410
Collaborators and investigators
Sponsor: Seagen Inc.
Collaborator: Sanofi