A Study of SGN-CD228A in Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT04042480 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2019
Last Update Posted : June 14, 2022
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Sponsor:
Seagen Inc.
Information provided by (Responsible Party):
Seagen Inc.
- Study Details
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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 HER2 Negative Breast Neoplasms Non-small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma | Drug: SGN-CD228A | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 210 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 |
|---|---|
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Experimental: SGN-CD228A
SGN-CD228A monotherapy
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Drug: SGN-CD228A
SGN-CD228A administered into the vein (IV; intravenously) |
Primary Outcome Measures :
- 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.
- Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 3.5 years ]
- Number of participants with dose limiting toxicities [ Time Frame: Up to approximately 3.5 years ]
Secondary Outcome Measures :
- Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 3.5 years ]
- Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only) [ Time Frame: Up to approximately 3.5 years ]
- 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.
- 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 (complete response [CR] or partial response [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 antibody-conjugated monomethylauristatin E (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 [AUC (0-last)] of acMMAE [ 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 anti-drug antibodies (ADA) [ Time Frame: Up to approximately 3.5 years ]
Information from the National Library of Medicine
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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
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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.
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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.
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Malignant pleural mesothelioma (MPM):
- Participants must have received cisplatin and pemetrexed unless contraindicated.
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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.
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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.
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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.
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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.
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- 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
Contacts
| Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| Contact: Dayle Craig 205-996-0134 dc0350@uab.edu | |
| Principal Investigator: Francisco Robert | |
| United States, California | |
| Angeles Clinic and Research Institute, The | Recruiting |
| Los Angeles, California, United States, 90025 | |
| 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, 60637-1470 | |
| Contact: Jose Torio 773-702-1341 jtorio@medicine.bsd.uchicago.edu | |
| Principal Investigator: Hedy L Kindler | |
| United States, North Carolina | |
| Wake Forest Baptist Medical Center / Wake Forest University | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Amanda L Gregson 336-716-2011 | |
| Principal Investigator: Caio Rocha-Lima | |
| United States, Ohio | |
| Case Western Reserve University / University Hospitals Cleveland Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Ashley Campbell 216-844-6088 | |
| Principal Investigator: Afshin Dowlati, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Andrzej Stadnik 503-494-2636 | |
| Principal Investigator: Shivaani Kummar | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Sarah Brodeur 412-647-2811 brodeurs@upmc.edu | |
| Principal Investigator: Diwakar Davar | |
| United States, South Dakota | |
| Sanford Cancer Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| Contact: Staci Vogel 605-328-8000 | |
| Principal Investigator: Steven Powell | |
| United States, Texas | |
| MD Anderson Cancer Center / University of Texas | Recruiting |
| Houston, Texas, United States, 77030 | |
| 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, Other, France, 94805 | |
| Principal Investigator: Eric Angevin | |
| Principal Investigator: Capucine Baldini | |
| Italy | |
| Istituto Europeo di Oncologia | Recruiting |
| Milano, Other, Italy, 20141 | |
| Principal Investigator: Giuseppe Curigliano | |
| Spain | |
| Hospital Universitario Vall d'Hebron | Recruiting |
| Barcelona, Other, Spain, 08035 | |
| Principal Investigator: Elena Garralda Cabanas | |
| Principal Investigator: Irene Brana | |
| United Kingdom | |
| The Royal Marsden Hospital (Surrey) | Recruiting |
| Sutton, Other, United Kingdom, SM2 5PT | |
| Principal Investigator: Johann de Bono | |
| Principal Investigator: Anna Minchom | |
Sponsors and Collaborators
Seagen Inc.
Investigators
| Study Director: | Anu Gupta, MD | 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: | June 14, 2022 |
| Last Verified: | June 2022 |
| 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 |
Keywords provided by Seagen Inc.:
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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 |