Actively Recruiting
Phase I Study of BPI-460372 to Evaluate Safety, Dosage, and Preliminary Effects in Patients with Advanced Solid Tumors
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2025-01-27
82
Participants Needed
11
Research Sites
155 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of BPI-460372 in patients with advanced solid tumors. The study focuses on patients who have locally advanced or metastatic solid tumors that have progressed after standard treatments or for whom no standard therapies exist. The study also includes patients with specific tumor types and genetic abnormalities related to the Hippo signaling pathway. Participants will receive the drug BPI-460372 continuously until their disease progresses. The study has two main parts: a dose escalation phase involving patients with various advanced solid tumors, and a dose expansion phase focusing on patients with malignant mesothelioma, epithelioid hemangioendothelioma, or other tumors with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, or other Hippo pathway abnormalities. Each phase requires measurable or evaluable tumor lesions for evaluation. During the approximately 24-month Phase 1 period, researchers will monitor adverse events, dose-limiting toxicities, and determine the maximum tolerated dose of BPI-460372. Participants will undergo regular safety and pharmacokinetic assessments to evaluate the drug's effects and tolerability. The study involves ongoing follow-up to track safety outcomes and gather preliminary data on the drug's impact on tumor progression.
CONDITIONS
Official Title
A Study of BPI-460372 in Advanced Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older, male or female
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- For dose escalation: confirmed locally advanced or metastatic solid tumor with disease progression after, intolerance to, refusal of, or no available standard therapy
- For dose expansion: confirmed locally advanced malignant mesothelioma, epithelioid hemangioendothelioma, or other solid tumors with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, or other Hippo signaling pathway abnormalities, with disease progression after, intolerance to, refusal of, or no available standard therapy
- Evaluable lesion required for dose escalation phase
- At least one measurable lesion per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase
You will not qualify if you...
- Previous treatment with a TEAD inhibitor
- Inadequate wash-out from prior therapies including anti-tumor therapies, adjuvant drugs, organ or stem cell transplantation
- Severe or unstable systemic diseases
- Unstable or symptomatic central nervous system metastasis, meningeal metastasis, or spinal cord compression
- Malignant tumors with cardiac disease, bleeding or embolic disease, infectious diseases, or conditions affecting drug swallowing and absorption
- Medical history leading to chronic diarrhea
- Pregnancy or lactation
- Any other conditions deemed inappropriate for trial participation by investigators
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 050031
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
5
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
Not Yet Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
7
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
Not Yet Recruiting
8
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250013
Actively Recruiting
9
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
10
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
Not Yet Recruiting
11
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Zhengzhou, China, 450052
Not Yet Recruiting
Research Team
M
Mengzhao Wang, Ph.D
X
Xiaohong Han, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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