Evaluating BPI-460372 for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, phase 1 study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BPI-460372 in patients with advanced solid tumors. The study includes a dose escalation phase for patients who have experienced disease progression after standard therapies and a dose expansion phase focusing on specific tumor types with certain genetic abnormalities. Participants will be monitored for their response to the treatment and any side effects that may arise.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Affiliated Hospital of Hebei University
  Baoding, Hebei, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Central Hospital Affiliated to Shandong First Medical University
  Jinan, Shandong, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Not yet recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting

Study contacts

• Study coordinator: Mengzhao Wang, Ph.D
• Email: mengzhaowang@sina.com
• Phone: 010-69155039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.