Clinical trialPhase 1Recruiting
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 27 May 2025
- Expected end
- November 2027
- Enrollment
- 68 participants
- Sites
- 1
- Primary outcomes
- Number of participants with dose-limiting toxicities (DLTs)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 1 July 2025
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.