A Study of BPI-460372 in Advanced Solid Tumor Patients
- Registration Number
- NCT05789602
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 82
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation BPI-460372 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). Dose Expansion BPI-460372 Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (11)
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Central Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Zhengzhou, China