Trial Title:
A Study of BPI-460372 in Advanced Solid Tumor Patients
NCT ID:
NCT05789602
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BPI-460372
Description:
Subjects will receive BPI-460372 until disease progression
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100032
Country:
China
Status:
Recruiting
Contact:
Last name:
Mengzhao Wang
Phone:
010-69155039
Email:
mengzhaowang@sina.com
Contact backup:
Last name:
Xiaohong Han
Phone:
010-69156114
Email:
hanxiaohong@pumch.cn
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yutao Liu
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Zip:
050031
Country:
China
Status:
Recruiting
Contact:
Last name:
Aimin Zang
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Yu
Facility:
Name:
Tongji Hospital Tongji Medical College of HUST
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qian Chu
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu
Facility:
Name:
China-Japan Union Hospital of Jilin University
Address:
City:
Changchun
Zip:
130033
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Linlin Liu
Facility:
Name:
Central Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
Meili Sun
Contact backup:
Last name:
Qing Wen
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ligang Xing
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
317000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dongqing Lv
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xingya Li
Start date:
April 24, 2023
Completion date:
April 17, 2026
Lead sponsor:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Betta Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789602
