BPI-460372: Subjects will receive BPI-460372 until disease progression
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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.
Trial sites (11)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Not Yet Recruiting
Affiliated Hospital of Hebei University
Baoding
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
China-Japan Union Hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan
Shandong
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Not Yet Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou
Zhejiang
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhengzhou
Not Yet Recruiting
More Betta Pharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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