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Brief Title: Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL001 in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT06410092
Brief Summary: This is an open, multi-center, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics and initial efficacy of FTL001 in patients with advanced and metastatic solid tumors.
Detailed Description: The study is divided into two phases, Part 1 (FTL001 dose escalation) and Part 2 (FTL001 dose expansion), and is intended to include approximately 26-44 participants.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
West China Hospital, Chengdu, Sichuan, China
Name: Yuankai Shi, MD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Shoubin Wen, MD
Affiliation: Sound Biopharmaceuticals Ltd.
Role: STUDY_DIRECTOR