Esophageal Cancer Clinical Trial
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Summary
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer:
that cannot be removed surgically
that has moved to other parts of the body
that got worse during or after treatment that included trastuzumab
The study will enroll about 80 participants. Sites will be in North America and the European Union.
Eligibility Criteria
Inclusion Criteria:
Men or women ≥18 years old (local regulatory guidelines apply)
Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
Has at least one measurable lesion per RECIST v1.1, as confirmed by investigator review
If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug
Exclusion Criteria:
Has had anticancer therapy after first-line treatment regimen containing trastuzumab
Has uncontrolled cardiovascular disease, including any of the following: history of myocardial infarction (MI) within 6 months of first dose or symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer within 28 days of first dose, or corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based on screening triplicate 12-lead electrocardiogram (ECG)
Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out at screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the first dose, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
Has pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms (Note: participants with clinically inactive brain metastases may be included in the study as well as participants with treated brain metastases who are no longer symptomatic and no longer require treatment with corticosteroids or anticonvulsants.
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There are 36 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Monterey California, 93940, United States
Santa Monica California, 90404, United States
Hartford Connecticut, 06102, United States
Meriden Connecticut, 06451, United States
New Britain Connecticut, 06052, United States
New Haven Connecticut, 06511, United States
Miami Florida, 33176, United States
Chicago Illinois, 60637, United States
Kansas City Kansas, 66205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
Lake Success New York, 11042, United States
New York New York, 10065, United States
Allentown Pennsylvania, 18103, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Brussels , 1200, Belgium
Haine-Saint-Paul , 7100, Belgium
Leuven , 3000, Belgium
Milano , 20133, Italy
Milano , 20162, Italy
Modena , 41124, Italy
Padua , 35128, Italy
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8908, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
Cambridge , CB2 0, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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