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Clinical Trials in China / NCT05789602
Recruiting Phase 1

A Study of BPI-460372 in Advanced Solid Tumor Patients

NCT05789602 · tracked via the Priya Life Science China tracker
Sponsor
Betta Pharmaceuticals Co., Ltd.
Phase
Phase 1
Started
2023-04-24
Last updated
2025-01-27

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

BPI-460372

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)

Trial sites (11)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05789602 on ClinicalTrials.gov ↗ ← All trials in China