Trials / Terminated
TerminatedNCT04074759
FPT155 in Patients With Advanced Solid Tumors
A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Five Prime Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.
Detailed description
This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | FPT155 | A soluble CD80 fusion protein |
| BIOLOGICAL | pembrolizumab | An anti-PD1 antibody |
Timeline
- Start date
- 2018-10-18
- Primary completion
- 2021-08-10
- Completion
- 2021-08-10
- First posted
- 2019-08-30
- Last updated
- 2025-01-23
- Results posted
- 2025-01-23
Locations
12 sites across 2 countries: Australia, South Korea
Source: ClinicalTrials.gov record NCT04074759. Inclusion in this directory is not an endorsement.