{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"}],"units":"Participants"}],"description":"To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib.\n\nDLT was evaluated in the DLT observation frame.","groups":[{"description":"Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.\n\nPatients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.","id":"OG000","title":"Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg"},{"description":"Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.\n\nPatients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.","id":"OG001","title":"Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg"},{"description":"Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.\n\nPatients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.","id":"OG002","title":"Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg"},{"description":"Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.\n\nPatients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.","id":"OG003","title":"Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg"},{"description":"Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.\n\nPatients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.","id":"OG004","title":"Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis:\n\n* Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations.\n* Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.","reportingStatus":"POSTED","timeFrame":"The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).","title":"Part A Dose Escalation: Dose Limiting Toxicities (DLTs).","type":"PRIMARY","unitOfMeasure":"Participants"}