A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
Status:
Not yet recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH)
study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2
dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles
observed after oral administration of SYHA1807. The dose escalation study will be performed
according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to
12~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of
SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).