Trials / Recruiting
RecruitingNCT06410092
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001
A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL001 in Patients With Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Sound Biopharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FTL001 | IV infusion every 2 weeks |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2026-01-01
- Completion
- 2027-03-01
- First posted
- 2024-05-10
- Last updated
- 2024-05-10
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06410092. Inclusion in this directory is not an endorsement.