A Study of BPI-460372 in Advanced Solid Tumor Patients
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBetta Pharmaceuticals Co., Ltd.
About this trial
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 criteria
Qualifiers
Signed informed consent;
Age ≥18, male and female patients；
Expected survival ≥ 3 months；
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- BPI-460372
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov