NCT02664961

Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

A Phase 2A Study of TRC105 (With Option to Add Bevacizumab) in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Tracon Pharmaceuticals Inc. · Industry
• Sex: Female
• Age: 16 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.

Detailed description

TRC105 is a monoclonal antibody that binds to endoglin, an angiogenic target highly expressed on the tumor vessels and tumor cells in gestational trophoblastic neoplasia (GTN). Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 has been well tolerated as a single agent and when combined with bevacizumab. These antibodies may be efficacious in refractory GTN, a tumor type that is highly vascular and has been shown to densely express endoglin.

Conditions

• Gestational Trophoblastic Neoplasia
• Choriocarcinoma
• Placental Site Trophoblastic Tumor
• Epithelioid Trophoblastic Tumor

Interventions

Type	Name	Description
DRUG	TRC105	Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
DRUG	Bevacizumab	Bevacizumab will be dosed every two weeks.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-04-01
• Completion: 2018-11-01
• First posted: 2016-01-27
• Last updated: 2019-07-23
• Results posted: 2019-06-04

Locations

3 sites across 1 country: United States