Chipscreen Biosciences, Ltd.
This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.
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 cohor…
Phase 1b Inclusion Criteria: 1. Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed 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. 2. Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease prog…
Phase 1b: Each patient will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period Phase 2: Patients will take the RP2D once daily for 28-day cycles continuously with no interruption between cycles