drugset / Trial / NCT03471663

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

NCT03471663

Phase 1 Completed 200 enrolled InventisBio Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

Timeline

Start
2018-03-18
Primary completion
2023-10-18
Completion
2023-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject TARAGARESTRANT Small molecule Oral
Background Palbociclib Small molecule

Indications