74
Participants
Start Date
October 10, 2024
Primary Completion Date
July 31, 2026
Study Completion Date
October 31, 2026
Dose escalation(IPM514 monotherapy)
Drug:IPM514 Intramuscular Injection A total of 7 administrations, including 2 cycles of vaccination with each cycle at QW × 3 doses; there is a 2-weeks interval between the two cycles, then followed by a boost dose 3 weeks after the 2'nd cycle.
Dose expansion (IPM514 combined with tislelizumab)
Drug:IPM514 Intramuscular Injection Drug:tislelizumab intravenous administration The usage and dosage of the tislelizumab will be based on the drug instructions. IPM514 administration is planned to be concomitant with PD-1 antibody and to be stopped after 9 doses of treatment, while the PD-1 antibody will be continuously administered for a maximum of 1 year.
Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)
Drug:IPM514 Intramuscular Injection Drug:tislelizumab intravenous administration Drug:cisplatin intravenous administration Drug:paclitaxel intravenous administration In this stage, subjects will receive the treatment of IPM514 combined with Tislelizumab, cisplatin and paclitaxel. All four drugs will be administered once every 3 weeks (± 1 day). IPM514 will be administered for the first time on D0, and Tislelizumab, cisplatin and paclitaxel will be administered for the first time on D3 (the administration order: Tislelizumab - paclitaxel - cisplatin). IPM514 will be administered a total of 3 times, and PD-1 antibody, cisplatin and paclitaxel will all be administered a total of 2 times (that is, IPM514 is administered on D0/D21/D42, and Tislelizumab, paclitaxel and cisplatin are administered on D3/D24).
RECRUITING
Peking University Cancer Hospital, Beijing
Peking University
OTHER