Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinoma

JRCT ID: jRCT2011210017

Registered date:17/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2-expressing recurrent and/or metastatic salivary gland carcinoma
• Date of first enrollment: 17/06/2021
• Target sample size: 52
• Study type: Interventional
• Intervention(s): DS-8201a 100 mg for injection is infused intravenously every 21 days (19-23 days) at a dose of 5.4 mg / kg based on the body weight of the subject.

Outcome(s)

• Primary Outcome: Objective Response Rate by the Independent Central Image Committee

Secondary Outcome

Efficacy: Best percent change in sum of diameter for tumor
Disease control rate
Progression free survival
Overall survival
Objective response rate by Principal Investigators
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

20 years and over at the time of written informed consent
Histologically confirmed recurrent and or metastatic salivary gland carcinoma
No indication for curative treatment
Tumor tissue or undryed glass specimen is available
IHC 3 plus IHC 2 plus IHC 1 plus and or ISH plus
Patient with measurable lesion by RECIST version 1.1
ECOG performance status of 0 or 1
Adequate organ function

Exclude criteria

History and complication of myocardial infarction or congestive heart failure
Prolonged QT interval
Complication of Interstitial lung disease
Active central nervous system metastasis
Other active malignancies
Prior treatment with ADC of Exatecan derivative Topoisomerase I inhibitor

Related Information

• Primary Sponsor: Hirotoshi Akita
• Secondary Sponsor: AKITA Hirotoshi
• Source(s) of Monetary Support: Daiichi Sankyo Company Limited