A Phase Ib/II Study of GT90001 Combined With KN046 in Solid Tumors
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Phase Ib is a dose De-escalation study to evaluate the safety, tolerability, pharmacokinetics
(PK) and preliminary antitumor activity of GT90001 in combination with KN046 in subjects with
advanced or refractory hepatocellular carcinoma (HCC), gastric carcinoma (GC) and
gastroesophageal junction (GEJ) adenocarcinoma, urothelial carcinoma (UC) and esophageal
square cell carcinoma (ESCC).
Phase II is to investigate anti-tumor efficacy of GT90001 in combination with KN046 at RP2D
in subjects with specific types of tumors. A Simon two-stage design is planned for each
indication in order to minimize the number of treated participants if there is minimal
efficacy activity in that indication.