A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
NCT ID: NCT05329298
Last Updated: 2022-04-15
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2021-07-21
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
NCT05315180
A Study of BPI-460372 in Advanced Solid Tumor Patients
NCT05789602
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors
NCT05302843
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
NCT05172856
A Study of BPI-452080 in Subjects With Solid Tumors
NCT05843305
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase I
Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia).
Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib).
BPI-361175
Subjects will receive BPI-361175 until disease progression
Phase II
Patients receive BPI-361175 based on RP2D.
BPI-361175
Subjects will receive BPI-361175 until disease progression
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BPI-361175
Subjects will receive BPI-361175 until disease progression
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
* For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
* Measurable or evaluable disease;
* Adequate bone marrow, liver, and renal function.
Exclusion Criteria
* Pregnancy or lactation;
* Other protocol specified criteria.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caicun Zhou, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Jianying Zhou, Ph.D
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan cancer hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Qiming Wang, Ph.D
Role: primary
Nong Yang, Ph.D
Role: primary
Yongqian Shu, Ph.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BTP-661411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.