A Study Of SGN-CEACAM5C In Adults With Advanced Solid Tumors

Study Overview

A Study of 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 of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given to participants in combination with bevacizumab. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with bevacizumab and if it works to treat a certain solid tumor.

N/A

Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Pancreatic Ductal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Small Cell Lung Carcinoma

DRUG: PF-08046050
DRUG: bevacizumab

SGNCEA5C-001
C5831001 (OTHER Identifier) (OTHER: Alias Study Number)
2023-505858-18-00 (REGISTRY Identifier) (REGISTRY: CTIS (EU))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-11
First Submitted that Met QC Criteria 2023-11-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-12
First Posted (ESTIMATED) 2023-11-14	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PF-08046050 PF-08046050 monotherapy	DRUG: PF-08046050 Given into the vein (IV; intravenous) DRUG: bevacizumab Given into the vein (IV; intravenous)
EXPERIMENTAL: PF-08046050 +bevacizumab PF-08046050 combination with bevacizumab	DRUG: PF-08046050 Given into the vein (IV; intravenous) DRUG: bevacizumab Given into the vein (IV; intravenous)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PF-08046050

PF-08046050 monotherapy

DRUG: PF-08046050

Given into the vein (IV; intravenous)

DRUG: bevacizumab

Given into the vein (IV; intravenous)

EXPERIMENTAL: PF-08046050 +bevacizumab

PF-08046050 combination with bevacizumab

DRUG: PF-08046050

Given into the vein (IV; intravenous)

DRUG: bevacizumab

Given into the vein (IV; intravenous)

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with adverse events (AEs)	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	Through 30-37 days after the last study 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 dose modifications due to AEs		Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)		Up to 28 days
Number of participants with DLTs by dose level		Up to 28 days

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)	PK endpoint	Through 30-37 days after the last study treatment, up to approximately 2 years
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)	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.	Through end of study and up to approximately 2 years
Best overall response	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.	Through end of study and up to approximately 2 years
Duration of response (DOR)	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	Through end of study and up to approximately 2 years
Progression-free survival (PFS)	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	Through end of study and up to approximately 2 years
Overall survival (OS)	OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause	Through end of study and up to approximately 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center

Phone Number: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 and must have received prior treatment (in 1 or more lines of therapy) containing fluoropyrimidine, oxaliplatin, and irinotecan.
PDAC and 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 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.
Participants in Part D (bevacizumab combination therapy dose escalation) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must have demonstrated progressive disease or intolerance to their last treatment regimen. Prior treatment regimens must have included fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wildtype participants.
Participants in Part E (bevacizumab combination therapy dose expansion) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must have received a maximum of 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated progressive disease or intolerance to their last regimen. Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wildtype participants. 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 bevacizumab 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sanofi

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record