96
Participants
Start Date
April 30, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
KM501
1a: The program evaluated six dose levels, i.e., 0.1, 0.3, 0.6, 1.2, 1.8, 2.4 mg/kg, An accelerated titration was performed in the 0.1 and 0.3 mg/kg dose groups, and then a Bayesian optimal interval design was used to determine MTDS for four subsequent dose levels. Ib: The antitumor activity of KM501 monotherapy in subjects with specific types of tumors that are HER2-positive or express, amplify, or mutate will be evaluated at the RP2D dose level
Tianjin Cancer Hospital, Tianjin
Xuanzhu Biopharmaceutical Co., Ltd.
INDUSTRY