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Brief Title: To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors
Official Title: To Evaluate the Safety and Tolerability of SYHX2001 in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT05407909
Brief Summary: This is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the experimental drug(SYHX2001) in previously treated patients with advanced or metastatic cancer.
Detailed Description: This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of SYHX2001(name of the experimental drug) in patients with advanced or metastatic cancers who have exhausted standard treatment. The study will consist of 2 parts, a dose escalation part and a cohort expansion part. Once the recommended phase 2 dose (RP2D) has been determined in the dose escalation part, a cohort expansion part involving up to three separate cohorts will be conducted. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of SYHX2001.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China