Advanced Solid Tumor
Conditions
Brief summary
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.
Interventions
DRUGBPI-460372
Subjects will receive BPI-460372 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
* Signed informed consent; * Age ≥18, male and female patients； * Expected survival ≥ 3 months； * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; * Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * Dose expansion phase: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;
Exclusion criteria
* Patients who have previously received a TEAD inhibitor; * Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc； * Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc; * Pregnancy or lactation; * Other conditions considered not appropriate to participate in this trial by the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| The dose-limiting toxicity（DLT） | Through the Phase I, approximately 24 months | The dose-limiting toxicity |
| Determine the Maximum Tolerated Dose (MTD) | Through the Phase I, approximately 24 months | The MTD will be based on DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacokinetics of BPI-460372 | Time Frame: Through the Phase I, approximately 24 months | Based on blood plasma concentration |
| Evaluate the effectiveness of BPI-460372 | Time Frame: Through the Phase I, approximately 24 months | Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1 |
Countries
China
Contacts
Primary ContactMengzhao Wang, Ph.D
Backup ContactXiaohong Han, Ph.D
Outcome results
None listed