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A Study of SGN-CD228A in 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042480
Recruitment Status : Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:
This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma Pleural Mesothelioma HER2 Negative Breast Neoplasms Non-small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma Drug: SGN-CD228A Phase 1

Detailed Description:
This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SGN-CD228A
SGN-CD228A monotherapy
Drug: SGN-CD228A
SGN-CD228A administered into the vein (IV; intravenously)




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to approximately 3.5 years ]
    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 3.5 years ]
  3. Number of participants with dose limiting toxicities [ Time Frame: Up to approximately 3.5 years ]

Secondary Outcome Measures :
  1. Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 3.5 years ]
  2. Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only) [ Time Frame: Up to approximately 3.5 years ]
  3. Objective response rate (ORR) [ Time Frame: Up to approximately 3.5 years ]
    A participant is determined to have an OR if they achieve a complete response (CR) or partial response (PR) after initiation of study treatment and at or prior to the end-of-treatment disease assessment.

  4. Progression-free survival (PFS) [ Time Frame: Up to approximately 3.5 years ]
    Defined as the time from the start of study treatment to first documentation of disease progression or death due to any cause, whichever comes first.

  5. Overall survival (OS) [ Time Frame: Up to approximately 3.5 years ]
    Defined as the time from the start of any study treatment to the date of death due to any cause.

  6. Duration of objective response (DOR) [ Time Frame: Up to approximately 3.5 years ]
    Defined as the time from start of the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of confirm tumor progression or death due to any cause, whichever comes first.

  7. Duration of complete response [ Time Frame: Up to approximately 3.5 years ]
    Defined as the time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first.

  8. Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE) [ Time Frame: Up to approximately 3.5 years ]
  9. Cmax of free MMAE [ Time Frame: Up to approximately 3.5 years ]
  10. Cmax of total antibody [ Time Frame: Up to approximately 3.5 years ]
  11. Time to maximum concentration (Tmax) of acMMAE [ Time Frame: Up to approximately 3.5 years ]
  12. Tmax of free MMAE [ Time Frame: Up to approximately 3.5 years ]
  13. Tmax of total antibody [ Time Frame: Up to approximately 3.5 years ]
  14. Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE [ Time Frame: Up to approximately 3.5 years ]
  15. AUC(0-last) of free MMAE [ Time Frame: Up to approximately 3.5 years ]
  16. AUC(0-last) of total antibody [ Time Frame: Up to approximately 3.5 years ]
  17. Trough concentration (Ctrough) of acMMAE [ Time Frame: Up to approximately 3.5 years ]
  18. Ctrough of free MMAE [ Time Frame: Up to approximately 3.5 years ]
  19. Ctrough of total antibody [ Time Frame: Up to approximately 3.5 years ]
  20. Incidence of anti-drug antibodies (ADA) [ Time Frame: Up to approximately 3.5 years ]


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

  • Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available. Disease-specific escalation/expansion includes the following tumor types.

    • Metastatic cutaneous melanoma(MCM):

      • Metastatic or advanced cutaneous melanoma, excludes acral or mucosal varieties.
      • Participants must have received at least 1 PD-1-targeted therapy unless contraindicated.
      • Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.
    • Malignant pleural mesothelioma (MPM):

      • Participants must have received cisplatin and pemetrexed unless contraindicated.
    • Advanced HER2-negative breast cancer:

      • Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane.
      • Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.
    • Advanced non-small cell lung cancer (NSCLC):

      • Participants must have locally advanced or metastatic EGFR wild-type NSCLC.
      • Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy as a single agent or as part of a combination unless contraindicated.
    • Advanced colorectal cancer:

      • Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.
    • Advanced pancreatic ductal adenocarcinoma (PDAC):

      • Participants must have unresectable or advanced PDAC.
      • Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.
  • Participants should be able to provide adequate tumor tissue for biomarker analysis
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion Criteria

  • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
  • Pre-existing neuropathy Grade 2 or greater
  • Retinal or macular disease requiring treatment or ongoing active monitoring
  • Prior receipt of SGN-CD228A or MMAE-containing agents

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): NCT04042480


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, North Carolina
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Dakota
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
France
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Italy
Istituto Europeo di Oncologia
Milano, Italy, 20141
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
United Kingdom
The Royal Marsden Hospital (Surrey)
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Anu Gupta, MD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04042480    
Other Study ID Numbers: SGN228-001
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
HER2-negative breast cancer
Seattle Genetics
Additional relevant MeSH terms:
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Mesothelioma
Breast Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Adenoma
Neoplasms, Mesothelial
Breast Diseases
Skin Diseases