Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum
tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2
(HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other
solid tumors that have no targeted agent as standard of care).
Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive
metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at
the RP2D (or MTD).