NCT06410131

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sound Biopharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	FTL008.16	IV infusion every 2 weeks

Timeline

• Start date: 2025-05-27
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-05-10
• Last updated: 2025-07-01

Locations

1 site across 1 country: China