Evaluating BPI-460372 for patients with advanced solid tumors

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

This study is testing a new drug called BPI-460372 to see if it is safe and effective for people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Betta Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 11 sites (Beijing, Beijing Municipality and 10 other locations)
• Trial ID: NCT05789602 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that have progressed after standard therapies or for whom no standard therapies exist.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited or no standard treatment alternatives.

How similar studies have performed: Other studies targeting similar advanced solid tumors with novel therapies have shown promise, indicating potential for success with this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 10 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Central Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Mengzhao Wang, Ph.D

Conditions Advanced Solid Tumor