A Study of BPI-460372 in Advanced Solid Tumor Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BPI-460372

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mengzhao Wang, Ph.D; Phone Number: 010-69155039; Email: mengzhaowang@sina.com
• Study Contact Backup: Name: Xiaohong Han, Ph.D; Phone Number: 010-69156114; Email: hanxiaohong@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xiaohong Han; Phone Number: 010-69156114; Email: hanxiaohong@pumch.cn
      • Contact: Mengzhao Wang; Phone Number: 010-69155039; Email: mengzhaowang@sina.com
    • Beijing, Beijing, China
      • Not yet recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Yutao Liu
  • Hebei
    • Baoding, Hebei, China, 050031
      • Recruiting
      • Affiliated Hospital of Hebei University
      • Contact: Aimin Zang
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin medical university cancer hospital
      • Contact: yan Yu
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Not yet recruiting
      • Tongji Hospital Tongji Medical College Of Hust
      • Contact: Qian Chu
  • Hunan
    • Changsha, Hunan, China, 410031
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Lin Wu
  • Jilin
    • Changchun, Jilin, China, 130033
      • Not yet recruiting
      • China-Japan Union Hospital of Jilin University
      • Contact: Linlin Liu
  • Shandong
    • Jinan, Shandong, China, 250117
      • Not yet recruiting
      • Shandong Cancer Hospital
      • Contact: Ligang Xing
    • Jinan, Shandong, China, 250013
      • Recruiting
      • Central Hospital Affiliated to Shandong First Medical University
      • Contact: Meili Sun
      • Contact: Qing Wen
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
      • Not yet recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Dongqing Lv
  • Zhengzhou
    • Zhengzhou, Zhengzhou, China, 450052
      • Not yet recruiting
      • The first affiliated hospital of Zhengzhou university
      • Contact: Xingya Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; 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).	Drug: BPI-460372; Subjects will receive BPI-460372 until disease progression
Experimental: Dose Expansion; Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD)	Drug: BPI-460372; Subjects will receive BPI-460372 until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Determine the Maximum Tolerated Dose (MTD)	The MTD will be based on DLT.	Through the Phase I, approximately 24 months
The dose-limiting toxicity（DLT）	The dose-limiting toxicity	Through the Phase I, approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pharmacokinetics of BPI-460372	Based on blood plasma concentration	Time Frame: Through the Phase I, approximately 24 months
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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): April 17, 2025
• Study Completion (Estimated): April 17, 2026

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BTP-661911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No