{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"2"}]}],"title":"Complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"28"},{"groupId":"OG008","value":"7"},{"groupId":"OG009","value":"13"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"7"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"1"},{"groupId":"OG014","value":"5"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"19"},{"groupId":"OG007","value":"28"},{"groupId":"OG008","value":"11"},{"groupId":"OG009","value":"16"},{"groupId":"OG010","value":"10"},{"groupId":"OG011","value":"14"},{"groupId":"OG012","value":"5"},{"groupId":"OG013","value":"15"},{"groupId":"OG014","value":"12"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"3"}]}],"title":"Progressive disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"1"}]}],"title":"Non-evaluable"}],"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":"Best overall response by independent central review was defined as the proportion of participants who achieved either complete response \\[CR\\], partial response \\[PR\\], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Best overall response was assessed in the Intent-to-Treat Analysis Set.","reportingStatus":"POSTED","timeFrame":"From 6 months postdose of last participant up to 3 years 5 months","title":"Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)","type":"SECONDARY","unitOfMeasure":"Participants"}