RecruitingPhase 1NCT05789602

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


Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

82 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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.

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Interventions

DRUGBPI-460372

Subjects will receive BPI-460372 until disease progression


Locations(11)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 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

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Zhengzhou, China

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NCT05789602


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