Phase 2 study of DS-8201a in subjects with gastric cancer [DESTINY-Gastric01]

A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223671

Enrollment

220

Registered

2017-10-05

Start date

2017-11-02

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

Gastric or gastroesophageal junction adenocarcinoma

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: - Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction. - Progression on and after at least 2 prior regimens which had to include a fluoropyrimidine and a platinum. - Has measurable disease assessed by the investigator based on RECIST version 1.1. - Has an ECOG PS of 0 to 1

Exclusion criteria

Exclusion criteria: - Has a medical history of clinically significant lung disease - Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy - Has had non-gastric or gastroesophageal junction primary malignancies within 3 years

Design outcomes

Primary

Measure	Time frame
efficacy The objective response rate RECIST Version 1.1	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Progression-free survival, Overall survival, Duration of response, Disease control rate, Time to treatment failure, Safety, Pharmacokinetic RECIST Version 1.1	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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