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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06131840
Recruitment Status : Recruiting
First Posted : November 14, 2023
Last Update Posted : June 4, 2024
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Pancreatic Ductal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Small Cell Lung Carcinoma Drug: SGN-CEACAM5C Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1 Study to Investigate SGN-CEACAM5C in Adults With Advanced Solid Tumors
Actual Study Start Date : November 20, 2023
Estimated Primary Completion Date : March 31, 2029
Estimated Study Completion Date : March 31, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SGN-CEACAM5C
SGN-CEACAM5C monotherapy
 Drug: SGN-CEACAM5C
Given into the vein (IV; intravenous)
Other Name: SAR445953


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Number of participants with laboratory abnormalities [ Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years ]
  3. Number of dose modifications due to AEs [ Time Frame: Through end of treatment up to approximately 2 years ]
  4. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  5. Number of participants with DLTs by dose level [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. 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

  2. PK parameter - Maximum concentration (Cmax) [ Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years ]
    PK endpoint

  3. 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

  4. PK parameter - Trough concentration (Ctrough) [ Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years ]
    PK endpoint

  5. Number of participants with antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years ]
  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06131840


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Julia Olson       jolson@coh.org   
Principal Investigator: Marwan G Fakih         
United States, Colorado
University of Colorado Hospital / University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Katherine Daniels    303-724-9848    KATHERINE.M.DANIELS@CUANSCHUTZ.EDU   
Principal Investigator: Sarah L Davis         
United States, Florida
Florida Cancer Specialists - Lake Nona Recruiting
Orlando, Florida, United States, 32827
Contact: Ingrid Acker    689-216-8500    Ingrid.Acker@scri.com   
Principal Investigator: Cesar Perez Batista, MD         
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Danielle Wendler    410-502-5140    JHCTN@jhmi.edu   
Principal Investigator: Nilofer S Azad         
United States, Michigan
South Texas Accelerated Research Therapeutics Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Shannon Fabrie    616-954-5559      
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, Tennessee
Tennessee Oncology-Nashville/Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute General Inquiry Inbox    844-482-4812    asksarah@SCRI.com   
Principal Investigator: Meredith Sellers Pelster         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Anjali Raina    713-792-3238    ARaina@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5259    isabel.jimenez@startsa.com   
Principal Investigator: Amita Patnaik         
United States, Utah
START Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Marie Asay    801-907-4770    marie.asay@startthecure.com   
Principal Investigator: Justin Call         
Canada, Quebec
Royal Victoria Hospital, McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Principal Investigator: Victoria Mandilaras         
Sponsors and Collaborators
Seagen Inc.
Sanofi
Investigators
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Study Director: Medical Monitor Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT06131840    
Other Study ID Numbers: SGNCEA5C-001
First Posted: November 14, 2023    Key Record Dates
Last Update Posted: June 4, 2024
Last Verified: June 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
CRC
NSCLC
PDAC
GC
 GEJ
SCLC
Seattle Genetics
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Stomach Diseases