Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
220

Summary

Conditions
Gastric Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will consist of 2 phases: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Part 1 will enroll HER2-overexpressing (IHC 3+ or IHC 2+/ISH+), previously treated gastric or gastro-esophageal junction (GEJ) cancer patients, and Part 2 will enroll HER2-overexpressing patients who have not received prior treatment for metastatic disease. In addition to safety and tolerability, this study will also assess ORR, DoR, DCR, OS, PFS and other measures of antitumor activity among treatment groups. Tumor evaluation using RECIST v1.1 will be conducted at screening and every 6 weeks until RECIST 1.1 objective disease progression or withdrawal of consent.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 130 years
Gender
Both males and females

Description

Not Provided

Not Provided

Tracking Information

NCT #
NCT04379596
Collaborators
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Investigators
Not Provided