A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients
Overview
- Phase
- Phase 1
- Intervention
- BPI-460372
- Conditions
- Advanced Solid Tumor
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 82
- Locations
- 11
- Primary Endpoint
- The adverse events (AEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD).
Intervention: BPI-460372
Dose Expansion
Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD)
Intervention: BPI-460372
Outcomes
Primary Outcomes
The adverse events (AEs)
Time Frame: 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）
Time Frame: Through the Phase I, approximately 24 months
The dose-limiting toxicity
Determine the Maximum Tolerated Dose (MTD)
Time Frame: Through the Phase I, approximately 24 months
The MTD will be based on DLT.
Secondary Outcomes
- Evaluate the pharmacokinetics of BPI-460372(Time Frame: Through the Phase I, approximately 24 months)
- Evaluate the effectiveness of BPI-460372(Time Frame: Through the Phase I, approximately 24 months)