Phase 1 study of DS-8201a in subjects with advanced solid malignant tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222926

Enrollment

278

Registered

2015-07-31

Start date

2015-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid malignant tumors

Interventions

investigational material(s) Generic name etc : DS-8201a INN of investigational material : trastuzumab deruxtecan Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
safety efficacy Part 1: Safety Part 2: Safety, Efficacy Assessment of tumor response to DS-8201a using RECIST ver. 1.1	—

Secondary

Measure	Time frame
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	—

Countries

Japan, North America

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026