63
Participants
Start Date
November 30, 2025
Primary Completion Date
November 30, 2027
Study Completion Date
December 31, 2028
Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Overexpression BTC
Subjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.
Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Moderate/Low BTC
Subjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER