Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients
NCT ID: NCT05369312
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
230 participants
INTERVENTIONAL
2022-06-30
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD).
BPI-442096
Subjects will receive BPI-442096 until disease progression
Dose Expansion
Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD)
BPI-442096
Subjects will receive BPI-442096 until disease progression
Interventions
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BPI-442096
Subjects will receive BPI-442096 until disease progression
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 and ≤75 years, male and female patients;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC 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 non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC patients), 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 required for dose expansion phase;
* Dose expansion only: Patients must have confirmation of tumour mutation status (including KRAS G12, Class-3 BRAF, NF1 LOF mutations, RTK mutations, amplifications or rearrangements).
* Adequate organ function;
Exclusion Criteria
* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
* Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, 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.
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yilong Wu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun yat-sen university
Guangzhou, Guangdong, China
Henan Tumor Hospital
Zhengzhou, Henan, China
Zhongshan Hospital affiliated to Fudan University
Xuhui, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BTP-661711
Identifier Type: -
Identifier Source: org_study_id
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