{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"70.8","value":"0"},{"groupId":"OG001","lowerLimit":"0.8","upperLimit":"90.6","value":"33.3"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"70.8","value":"0"},{"groupId":"OG003","lowerLimit":"35.9","upperLimit":"99.6","value":"83.3"},{"groupId":"OG004","lowerLimit":"4.3","upperLimit":"77.7","value":"33.3"},{"groupId":"OG005","lowerLimit":"11.8","upperLimit":"88.2","value":"50.0"},{"groupId":"OG006","lowerLimit":"36.6","upperLimit":"65.2","value":"51.0"},{"groupId":"OG007","lowerLimit":"41.1","upperLimit":"66.0","value":"53.7"},{"groupId":"OG008","lowerLimit":"14.6","upperLimit":"57.0","value":"33.3"},{"groupId":"OG009","lowerLimit":"22.9","upperLimit":"57.9","value":"39.4"},{"groupId":"OG010","lowerLimit":"9.1","upperLimit":"51.2","value":"26.3"},{"groupId":"OG011","lowerLimit":"14.9","upperLimit":"53.5","value":"32.0"},{"groupId":"OG012","lowerLimit":"30.8","upperLimit":"78.5","value":"55.6"},{"groupId":"OG013","lowerLimit":"0.1","upperLimit":"24.9","value":"5.0"},{"groupId":"OG014","lowerLimit":"13.2","upperLimit":"52.9","value":"30.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"51"},{"groupId":"OG007","value":"67"},{"groupId":"OG008","value":"21"},{"groupId":"OG009","value":"33"},{"groupId":"OG010","value":"19"},{"groupId":"OG011","value":"25"},{"groupId":"OG012","value":"18"},{"groupId":"OG013","value":"20"},{"groupId":"OG014","value":"23"}],"units":"Participants"}],"description":"Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response \\[CR\\] or partial response \\[PR\\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).","id":"OG000","title":"Dose Escalation: Cohort 1, 0.8 mg/kg"},{"description":"Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).","id":"OG001","title":"Dose Escalation: Cohort 2, 1.6 mg/kg"},{"description":"Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).","id":"OG002","title":"Dose Escalation: Cohort 3, 3.2 mg/kg"},{"description":"Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG003","title":"Dose Escalation: Cohort 4, 5.4 mg/kg"},{"description":"Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG004","title":"Dose Escalation: Cohort 5, 6.4 mg/kg"},{"description":"Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).","id":"OG005","title":"Dose Escalation: Cohort 6, 8.0 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG006","title":"Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG007","title":"Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG008","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG009","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG010","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG011","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg"},{"description":"Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG012","title":"Dose Expansion: HER2-expressing NSCLC Tumors"},{"description":"Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG013","title":"Dose Expansion: HER2-expressing Colorectal Tumors"},{"description":"Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG014","title":"Dose Expansion: HER2-expressing Other Solid Tumors"}],"paramType":"NUMBER","populationDescription":"ORR was assessed among participants in the Intent-to-Treat Analysis Set.","reportingStatus":"POSTED","timeFrame":"From 6 months postdose of last participant up to 3 years 5 months","title":"Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}