Phase 1 study of DS-8201a in subjects with advanced solid malignant tumors
Phase 1 study of DS-8201a in subjects with advanced solid malignant tumors
Inoguchi Akihiro
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
Contact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
completed
Sept. 04, 2015
278
Interventional
Multicenter, non-randomized, open-label
Part 1: dose escalation, Part 2: dose expansion
treatment purpose
1
1. Age >= 20 years in Japan, >= 18 years in the United States.
2. Eastern Cooperative Oncology Group performance status(PS) of 0 or 1.
3. Left ventricular ejection fraction (LVEF) >= 50%
Part 1:
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:
1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2.Treated with T-DM1
Part 2b:
1. 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.
2. Treated with trastuzumab
Part 2c:
1. 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
1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2. Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
1. Has a medical history of symptomatic CHF (New York Heart Association; NYHA classes II-IV) or serious cardiac arrhythmia.
2. Has a medical history of myocardial infarction or unstable angina.
3. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
4. Has a medical history of clinically significant lung diseases
20age old over
No limit
Both
advanced solid malignant tumors
investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
safety
efficacy
Part 1: Safety
Part 2: Safety, Efficacy
Assessment of tumor response to DS-8201a using RECIST ver. 1.1
pharmacokinetics
exploratory
Part 1: Pharmacokinetics, Incidence of human anti-human antibodies (HAHA) against DS-8201a, Efficacy
Part 2: Pharmacokinetics, Incidence of human anti-human antibodies (HAHA) against DS-8201a
