NCT02318329

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Five Prime Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Detailed description

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients. Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.

Conditions

• Advanced Solid Tumors
• Gastric Cancer
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	FPA144	FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-02-28
• Completion: 2019-06-30
• First posted: 2014-12-17
• Last updated: 2024-06-04
• Results posted: 2020-03-11

Locations

26 sites across 3 countries: United States, South Korea, Taiwan