This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.
Male or female ≥ 18 years old;
Life expectancy ≥ 12 weeks;
Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic NSCLC with EGFR mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment.
Presence of another active primary malignant tumors;
Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators. A patient can be enrolled if his/her clinical condition is stable and imaging evidence does not show disease progression within 2 weeks prior to the first dose, and who is off corticosteroid, anticonvulsant or mannitol treatment for longer than 2 weeks prior to the first dose.
Treatment with the most recent therapy (e.g., chemotherapy, immunotherapy, targeted therapy, radiation therapy, investigational therapy/agent) within 4 weeks or approximately 5 half-lives, whichever is the longer, before the first dose. (If sufficient wash-out time has not occurred due to schedule or PK properties, an alternative appropriate wash-out time based on known duration and time to reversibility of drug related adverse events could be agreed upon by the sponsor and investigators);
Gastrointestinal disorders that would affect oral swallowing or the investigators judge the absorption of the study drug will be interfered;
Sequential
BPI-361175
DrugBPI-361175 is an oral fourth-generation EGFR inhibitor. The activation of EGFR signaling pathways is associated with various biological events such as proliferation, migration, differentiation, and apoptosis.
The percentage of patients with adverse events and serious adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events and dose limiting toxicities for BPI 361175
To characterize the pharmacokinetics (PK) of BPI-361175 tablets in advanced NSCLC
Efficacy of BPI-361175
To determine the recommended Phase II dose (RP2D).
Tmax
Time to maximum plasma concentration
Tumor assessments
RECIST
Determine maximum tolerated dose in milligrams of BPI-361175
MTD
Cmax
maximum plasma concentration
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This trial is not recruiting at the moment. You can still explore other options:
