drugset / Trial / NCT02802423

Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.

NCT02802423 ↗

Phase 1/2 Not yet recruiting 44 enrolled BioLite, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.

Timeline

Start
2027-01-01
Primary completion
2028-04-30
Completion
2028-08-28

Drugs

EvaluationDrugModalityDoseRoute
Subject BLEX 404 Unknown 3 mg/kg Oral
Subject BLEX 404 Unknown 10 mg/kg Oral