A Study of BPI-460372 in Advanced Solid Tumor Patients

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789602
• Other study ID #: BTP-661911
• Status: Recruiting
• Phase: Phase 1
• Start date: April 24, 2023
• Est. completion date: April 17, 2026

Study information

• Verified date: March 2023
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Mengzhao Wang, Ph.D
• Phone: 010-69155039
• Email: mengzhaowang[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: April 17, 2026
• Est. primary completion date: April 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BPI-460372
Subjects will receive BPI-460372 until disease progression

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tongji Hospital Tongji Medical College of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The adverse events (AEs)	Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).	Through the Phase I, approximately 24 months
Primary	The dose-limiting toxicity(DLT)	The dose-limiting toxicity	Through the Phase I, approximately 24 months
Primary	Determine the Maximum Tolerated Dose (MTD)	The MTD will be based on DLT.	Through the Phase I, approximately 24 months
Secondary	Evaluate the pharmacokinetics of BPI-460372	Based on blood plasma concentration	Time Frame: Through the Phase I, approximately 24 months
Secondary	Evaluate the effectiveness of BPI-460372	Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1	Time Frame: Through the Phase I, approximately 24 months