{"entity":{"id":"nct07122063","kind":"trial","name":"Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of SYS6045 in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., active and no longer recruiting.","summary":"Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07122063 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 266 participants enrolled, started 2025-08-11 and due to reach its primary completion in 2027-07-30. Interventions recorded: SYS6045.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07122063","url":"https://clinicaltrials.gov/study/NCT07122063"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07122063","phase":"1/2","setting":"A Multicenter, Open-Label Phase I/II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","participation":[{"nct":"NCT07122063","source":"https://clinicaltrials.gov/study/NCT07122063","fetchedAt":"2026-10-07T16:55:27.525Z","studySha256":"c0c94681a56a57fe97f83a5e3ced5f8d7f619afeb6fc92fe78115d6017c0d2f0","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2025-08-14","leadSponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":266,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":0,"countries":["China"]}],"started":"2025-08-11","startedType":"actual","enrolled":266,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07122063/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"company":[{"id":"cspc","kind":"company","name":"CSPC Pharmaceutical Group","route":"/companies/cspc/"}]}}