Non-small Cell Lung Cancer
Conditions
Brief summary
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
Interventions
DRUGBPI-361175
Subjects will receive BPI-361175 until disease progression
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years old; * Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist; * For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing; * Measurable or evaluable disease; * Adequate bone marrow, liver, and renal function.
Exclusion criteria
* Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators; * Pregnancy or lactation; * Other protocol specified criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: The adverse events (AEs) | Through the Phase I, approximately 24 months | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs). |
| Phase I: Determine the recommended Phase II dose (RP2D) | Through the Phase I, approximately 24 months | Number of subjects with dose limiting toxicity |
| Phase II: the objective response rate (ORR) | Through the Phase II, approximately 24 months | The proportion of patients with complete response (CR) and partial response (PR) in all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: the objective response rate (ORR) | Through the Phase I, approximately 24 months | The proportion of patients with complete response (CR) and partial response (PR) in all patients. |
| Phase II: Disease control rate (DCR) | Through the Phase II, approximately 24 months | The proportion of patients with CR, PR and stable disease (SD) in all patients. |
| Phase II: Progression free survival (PFS) | Through the Phase II, approximately 24 months | The time from the first study dose to disease progression (PD) or death, whichever occurs first. |
| Phase II: Duration of response (DOR) | Through the Phase II, approximately 24 months | The time from the first CR or PR to the first PD or death due to any cause. |
| Phase I: Disease control rate (DCR) | Through the Phase I, approximately 24 months | The proportion of patients with CR, PR and stable disease (SD) in all patients. |
| Phase I: Progression free survival (PFS) | Through the Phase I, approximately 24 months | The time from the first study dose to disease progression (PD) or death, whichever occurs first. |
| Phase I: Overall survival (OS) | Through the Phase I, approximately 24 months | The time from the first study dose to death due to any cause. |
| Phase II: Overall survival (OS) | Through the Phase II, approximately 24 months | The time from the first study dose to death due to any cause. |
| Phase II: The adverse events (AEs) | Through the Phase II, approximately 24 months | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs). |
| Phase I: Evaluate the pharmacokinetics of BPI-361175 | Through the Phase I, approximately 24 months | Blood plasma concentration |
Countries
China
Contacts
Primary ContactCaicun Zhou, Ph.D
Backup ContactJianying Zhou, Ph.D
Outcome results
None listed