Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: DS-8201a (DP1); DS-8201a (DP2); DS-8201a (DP)
Intervention description: DS-8201a to be administered via intravenous (IV) dose. DS-8201a (DP1) was used for the Dose Escalation phase and for Dose expansion Parts 2a, 2b, 2c, and 2d.; DS-8201a is to be administered via intravenous (IV) dose. DS-8201a (DP2) was used only used for Dose Expansion Part 2e.; DS-8201a (DP) is to be administered via intravenous (IV) dose.
Intervention MeSH terms: Camptothecin; Trastuzumab deruxtecan; Immunoconjugates
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumors; phase 1; oncology; HER2; Antibody drug conjugate (ADC)

Summary:

      This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of
      DS-8201a in participants with advanced solid malignant tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.

          -  Left Ventricular Ejection Fraction (LVEF) ≥ 50%

        Part 1:

          -  Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal
             junction adenocarcinoma that is refractory to or intolerable with standard treatment,
             or for which no standard treatment is available.

        Part 2a:

          -  Advanced breast cancer with HER2 overexpression that is refractory to or intolerable
             with standard treatment, or for which no standard treatment is available.

          -  Treated with ado-trastuzumab emtansine (T-DM1)

        Part 2b:

          -  Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
             that is refractory to or intolerable with standard treatment, or for which no standard
             treatment is available.

          -  Treated with trastuzumab

        Part 2c:

          -  Advanced breast cancer with HER2 low expression that is refractory to or intolerable
             with standard treatment, or for which no standard treatment is available.

        Part 2d:

          -  Satisfy at least one of the following criteria

               1. Advanced/unresectable or metastatic solid malignant tumor with HER2 expression
                  other than breast cancer and gastric or gastroesophageal junction adenocarcinoma
                  that is refractory to or intolerable with standard treatment, or for which no
                  standard treatment is available.

               2. Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory
                  to or intolerable with standard treatment, or for which no standard treatment is
                  available.

        Part 2e:

          -  Advanced breast cancer with HER2 overexpression that is refractory to or intolerable
             with standard treatment, or for which no standard treatment is available.

          -  Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression
             only)

        Exclusion Criteria:

          -  Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes
             II-IV) or serious cardiac arrhythmia.

          -  Has a medical history of myocardial infarction or unstable angina.

          -  Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.

          -  Has a medical history of clinically significant lung diseases