HERALD Study

Phase 2

Completed

• Conditions: solid malignancies

• Registration Number: JPRN-jRCT2080224635
• Lead Sponsor: Aichi Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.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.

Exclusion Criteria

1.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified