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A Study of SGN-CD228A in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04042480
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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 Breast Cancer 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 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 : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SGN-CD228A
SGN-CD228A administered intravenously
 Drug: SGN-CD228A
SGN-CD228A administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Up to approximately 3.5 years ]
  2. Number of patients with laboratory abnormalities [ Time Frame: Up to approximately 3.5 years ]
  3. Number of patients with dose limiting toxicities [ Time Frame: Up to approximately 3.5 years ]

Secondary Outcome Measures :
  1. Best response per RECIST [ Time Frame: Up to approximately 3.5 years ]
  2. Best response per mRECIST (participants with pleural mesothelioma only) [ Time Frame: Up to approximately 3.5 years ]
  3. Objective response (OR) rate [ 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 (CR or 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 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 [ 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 antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 3.5 years ]

Eligibility Criteria
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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.

  • Dose escalation

    • Advanced cutaneous melanoma
    • Malignant pleural mesothelioma (MPM)
    • Advanced HER2-negative breast cancer
    • Advanced non-small cell lung cancer (NSCLC)
    • Advanced colorectal cancer
    • Advanced pancreatic ductal adenocarcinoma (PDAC)

  • Disease-specific dose expansion

    • 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.
    • MPM: Participants must have received cisplatin and pemetrexed unless contraindicated.
    • Advanced HER2- 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 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 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.
    • 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) at baseline

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 SGN228A or MMAE-containing agents
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): NCT04042480


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

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Dayle Craig       dc0350@uab.edu   
Principal Investigator: Francisco Robert         
United States, California
Angeles Clinic and Research Institute, The Recruiting
Santa Monica, California, United States, 90404
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
Principal Investigator: Ani Balmanoukian, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Jose Torio       jtorio@medicine.bsd.uchicago.edu   
Principal Investigator: Hedy Kindler         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cancer Information Services Inbox    800-641-2422      
Principal Investigator: Afshin Dowlati, MD         
United States, Pennsylvania
Hillman Cancer Center / University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sarah Brodeur       brodeurs@upmc.edu   
Principal Investigator: Diwakar Davar         
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: ClinicalTrials.Gov Posting Inbox    605-328-1365      
Principal Investigator: Steven Powell         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Julia Moore    713-792-5199    jmoore@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265    isabel.jimenez@startsa.com   
Principal Investigator: Amita Patnaik, MD, FRCP(C)         
France
Institut Gustave Roussy Recruiting
Villejuif-Cedex, France, 94805
Principal Investigator: Capucine Baldini         
Italy
Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Principal Investigator: Giuseppe Curigliano         
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Elena Garralda Cabanas         
United Kingdom
The Royal Marsden Hospital (Surrey) Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Anna Minchom         
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Phillip Garfin, MD, PhD Seagen Inc.
More Information
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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: December 9, 2020
Last Verified: December 2020
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
Neoplasms
Neoplasms by Histologic Type
 Neoplasms, Glandular and Epithelial
Adenoma
Neoplasms, Mesothelial