DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Condition: Adenocarcinoma Gastric Stage IV With Metastases; Adenocarcinoma - GEJ
MeSH terms: Adenocarcinoma
Intervention: Trastuzumab deruxtecan
Intervention description: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion
Intervention MeSH terms: Trastuzumab; Trastuzumab deruxtecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human epidermal receptor 2 positive; Unresectable or metastatic; HER2; Prior treatment regimen included trastuzumab

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.