NCT03062007

Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biointegrator LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. After the Data and Safety Monitoring Committee evaluates the data of tolerability and safety of BI-CON-02, received during 3 weeks of investigational product therapy (Week 3, Day 1) and approves, extra doses can be used. Once the safety of investigational product is confirmed, the dose will be increased in the subsequent cohorts. Planned doses - 0,3 mg/kg; 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and 4,8 mg/kg.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	BI-CON-02	BI-CON-02 prescribed as intravenous infusion once per 3 weeks. Investigational product therapy during 1 year (up to 18 cycles, duration of 21 days each).

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2017-02-23
• Last updated: 2019-07-16

Locations

6 sites across 1 country: Russia