DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

Completed · Phase 2

Conditions studied: Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ

In brief

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.

Key facts

Study ID

NCT04014075

Run by

Daiichi Sankyo

People needed

79

Starts

2019-11-26

Expected to finish

2024-02-13

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• USC Norris Comprehensive Cancer Center Hospital — Los Angeles, California, United States
• Pacific Cancer Care — Monterey, California, United States
• UCLA Health — Santa Monica, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MidState Medical Center — Meriden, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Miami Cancer Institute, Baptist Health South Florida — Miami, Florida, United States
• University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM — Chicago, Illinois, United States
• Kansas University Cancer Center — Kansas City, Kansas, United States
• Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Alvin J. Siteman Cancer Center Washington University — St Louis, Missouri, United States
• Northwell Health Cancer Institute — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States
• UCL St-Luc — Brussels, Belgium
• Hopital de Jolimont — Haine-Saint-Paul, Belgium
• UZ Leuven — Leuven, Belgium
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
• Asst Grande Ospedale Metropolitano Niguarda — Milan, Italy

Full record on ClinicalTrials.gov

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