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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BPI-460372
DrugSubjects will receive BPI-460372 until disease progression
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Time frame
Through the Phase I, approximately 24 months2
The dose-limiting toxicity（DLT）
The dose-limiting toxicity
Time frame
Through the Phase I, approximately 24 months3
Determine the Maximum Tolerated Dose (MTD)
The MTD will be based on DLT.
Time frame
Through the Phase I, approximately 24 monthsSecondary outcomes
1
Evaluate the pharmacokinetics of BPI-460372
Based on blood plasma concentration
Time frame
Time Frame: Through the Phase I, approximately 24 months2
Evaluate the effectiveness of BPI-460372
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1
Time frame
Time Frame: Through the Phase I, approximately 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov