A Study of SGN-CD228A in Advanced Solid Tumors
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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: NCT04042480 |
Recruitment Status :
Recruiting
First Posted : August 2, 2019
Last Update Posted : December 9, 2020
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: SGN-CD228A
SGN-CD228A administered intravenously
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Drug: SGN-CD228A
SGN-CD228A administered intravenously |
- Number of patients with adverse events [ Time Frame: Up to approximately 3.5 years ]
- Number of patients with laboratory abnormalities [ Time Frame: Up to approximately 3.5 years ]
- Number of patients with dose limiting toxicities [ Time Frame: Up to approximately 3.5 years ]
- Best response per RECIST [ Time Frame: Up to approximately 3.5 years ]
- Best response per mRECIST (participants with pleural mesothelioma only) [ Time Frame: Up to approximately 3.5 years ]
- 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.
- 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.
- 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.
- 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.
- 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.
- Maximum concentration (Cmax) of acMMAE [ Time Frame: Up to approximately 3.5 years ]
- Cmax of free MMAE [ Time Frame: Up to approximately 3.5 years ]
- Cmax of total antibody [ Time Frame: Up to approximately 3.5 years ]
- Time to maximum concentration (Tmax) of acMMAE [ Time Frame: Up to approximately 3.5 years ]
- Tmax of free MMAE [ Time Frame: Up to approximately 3.5 years ]
- Tmax of total antibody [ Time Frame: Up to approximately 3.5 years ]
- Area under the plasma concentration-time curve from time 0 to the last available [ Time Frame: Up to approximately 3.5 years ]
- AUC(0-last) of free MMAE [ Time Frame: Up to approximately 3.5 years ]
- AUC(0-last) of total antibody [ Time Frame: Up to approximately 3.5 years ]
- Trough concentration (Ctrough) of acMMAE [ Time Frame: Up to approximately 3.5 years ]
- Ctrough of free MMAE [ Time Frame: Up to approximately 3.5 years ]
- Ctrough of total antibody [ Time Frame: Up to approximately 3.5 years ]
- Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 3.5 years ]

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

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
Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
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 |
Study Director: | Phillip Garfin, MD, PhD | Seagen Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HER2-negative breast cancer Seattle Genetics |
Mesothelioma Neoplasms Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Adenoma Neoplasms, Mesothelial |