NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-194707

Registered date:11/04/2019

HERALD Study

Basic Information

Recruitment status recruiting
Health condition(s) or Problem(s) studiedsolid malignancies
Date of first enrollment07/10/2019
Target sample size60
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : DS-8201a INN of the intervention : - Dosage And administration of the intervention : DS-8201a (5.4mg/kg) is administrated i.v. on day1, repeated every 21 days. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomeefficacy objective response rate(ORR) assessed by investigators
Secondary Outcomesafety, efficacy Progression-free survival: PFS Duration of response: DoR Time to treatment failure: TTF Disease control rate: DCR Overall survival: OS ORR by central assessment Changes of sum of tumor diameter AE

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteria1. Informed consent for participation in the study is obtained at the discretion of the patient. 2. The patient is 20 years of age or older on the date of informed consent. 3. Histologically or cytologically confirmed an unresectable advanced or recurrent solid malignancy who are refractory or intolerant to stanard therapy. 4. HER2 genomic amplified is detected by analysis of blood sample using Guardant360: 5. The disease is measurable based on the Response Evaluation Criteria in Solid Tumours (RECIST) guidelines version 1.1. 6.Adequate organ function 7.Males and women of childbearing potential who are negative in a urine pregnancy test agree to use contraception from obtaining informed consent through 4.5months after the final administration of DS-8201a.
Exclude criteria1. Has a history of prior treatment with antibody-drug conjugate (ADC) consists of DS-8201a or an exatecan derivative. 2.Patients with stomach cancer, breast cancer, colorectal cancer, lung cancer, biliary tract cancer, uterine cancer sarcoma and osteosarcoma, who high expression of HER2 has been confirmed by evaluation by tumor tissue assessment. 3.Has spinal cord compression or clinically active central nervous system metastases. 4.Patients with uncontrolled acute systemic infection or diabetes mellitus. 5.Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment. 6.Have a history of other malignancies within 3 years prior to enrollment. 7.Has HIV infection. Patients who are HBs antigen positive or HBs antibody or HBc antibody positive and HBV-DNA positive. Or have active hepatitis C. 8.Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 9.having a clinically relevant corneal disease.

Related Information

Contact

public contact
Name National Cancer Center Hospital East Clinical Research Support office
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Telephone
E-mail HERALD_core@east.ncc.go.jp
Affiliation
scientific contact
Name Aichi Cancer Center Hospital Department of Clinical Oncology
Address 1-1 Kanokoden, Chikusa-ku Nagoya 464-8681
Telephone
E-mail HERALD_core@east.ncc.go.jp
Affiliation