Spots Global Cancer Trial Database for Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
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Trial Identification
Brief Title: Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL008.16, a Recombinant Anti-CD137 and Anti-5T4 Bispecific Antibody, in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT06410131
Conditions
Interventions
Study Description
Brief Summary: This is an open, multi-center, multi-cohort phase I clinical study designed to evaluate safety, tolerability, pharmacokinetics and initial efficacy of FTL008.16 in patients with advanced and metastatic solid tumors.
Detailed Description: This study is divided into two phases: Part 1(dose escalation of FTL008.16) and Part 2(dose extension of FTL008.16), which is intended to include about 40 to 68 subjects.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Contact Details
Name: Ning Li, 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
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