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

April 19, 2024 updated by: Seagen Inc.

An Open-label Phase 1 Study to Investigate 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.

Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs.

This clinical trial uses an experimental drug called SGN-CEACAM5C. SGN-CEACAM5C 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 SGN-CEACAM5C in participants with solid tumors that are hard to treat or have spread throughout the body.

This study will have 3 parts. Part A and Part B of the study will find out how much SGN-CEACAM5C should be given to participants. Part C will use the information from Parts A and B to see if SGN-CEACAM5C is safe and if it works to treat solid tumor cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Phase 1

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

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Marwan G Fakih
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital / University of Colorado
        • Contact:
        • Principal Investigator:
          • Sarah L Davis
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists - Lake Nona
        • Principal Investigator:
          • Cesar Perez Batista, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Medical Center
        • Contact:
        • Principal Investigator:
          • Nilofer S Azad
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • South Texas Accelerated Research Therapeutics Midwest
        • Principal Investigator:
          • Nehal Lakhani, MD, PhD
        • Contact:
          • Shannon Fabrie
          • Phone Number: 616-954-5559
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
        • Principal Investigator:
          • Meredith Sellers Pelster
        • Contact:
          • Sarah Cannon Research Institute General Inquiry Inbox
          • Phone Number: 844-482-4812
          • Email: asksarah@SCRI.com
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Principal Investigator:
          • Funda Meric-Bernstam
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics
        • Principal Investigator:
          • Amita Patnaik
        • Contact:
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
        • Principal Investigator:
          • Justin Call
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Tumor type:

    1. 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)

    2. 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 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

    1. Dose optimization
    2. 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).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGN-CEACAM5C
SGN-CEACAM5C monotherapy
Drug: SGN-CEACAM5C
Given into the vein (IV; intravenous)
Other Names:
  • SAR445953

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with DLTs by dose level
Time Frame: Up to 28 days
Up to 28 days
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
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years
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
Through end of treatment up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
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 endpoint
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 endpoint
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 endpoint
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
PK endpoint
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
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.
Through end of study and up to approximately 2 years
Best response
Time Frame: 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.
Through end of study and up to approximately 2 years
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
Through end of study and up to approximately 2 years
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
Through end of study and up to approximately 2 years
Overall survival (OS)
Time Frame: 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
Through end of study and up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Collaborators

Sanofi

Investigators

  • Study Director: Medical Monitor, Seagen Inc.

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 Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNCEA5C-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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