Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.

Summary

Objectives

Phase 1b:

Patients with advanced solid malignant tumor (including SCLC, NSCLC, colorectal
carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine
tumors, non-Hodgkin's lymphoma and others) that has relapsed from or is refractory to
standard therapy or for which no standard therapy exists will be enrolled to the 35 mg,
50 mg and 65 mg dose cohorts in this stage. The starting dose is 35 mg, and each higher
dose cohort will not enroll until the lower dose is deemed safe.

After screening, eligible patients will be enrolled sequentially in 3 dose-escalating
cohorts. Based on an estimated average body weight of 60 kg, the initial dose of
chiauranib will be 35 mg once daily, and the dose will be escalated to 50 mg and 65 mg
once daily, depending on the occurrence and frequency of DLTs. The 3+3 design will be
employed in dose escalation decisions.

Each dose cohort will enroll at least 3 patients. Overenrolling dosing cohorts is allowed
to allow for potential screen failures and/or subjects who end up being not evaluable by
not completing the DLT evaluation period. Each subject will undergo both a single-dose
period (6 days) and a consecutive-dose (1 cycle of 28 days) period, as described below.
DLTs will be evaluated during this period (a total of 34 days).

Phase 2:

SCLC patients with progressive disease or recurrence after at least 2 previous regimens,
including one platinum-based chemotherapy, will be enrolled in this stage. The RP2D will
be given to all subjects enrolled in this stage. Subjects will take the RP2D chiauranib
once daily for 28-day cycles continuously with no interruption between cycles.