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.
COMPLETED
PHASE1
68 participants
INTERVENTIONAL
2021-09-08
2025-07-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LP-118
The classic "3+3" design at dose levels of 50mg, 100mg, 200mg, 300mg, 400mg and 500mg will be implemented in this study.
LP-118 tablet
Subjects will administered orally with LP-118 tablet at the designated dose once daily, using approximately 240 mL of water during a meal or within 30 minutes after a meal, 28 days per cycle. The treatment will continue until progressive disease, unacceptable toxicity, etc.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LP-118 tablet
Subjects will administered orally with LP-118 tablet at the designated dose once daily, using approximately 240 mL of water during a meal or within 30 minutes after a meal, 28 days per cycle. The treatment will continue until progressive disease, unacceptable toxicity, etc.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects have a life expectancy of ≥12 weeks, and Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
* Subjects must have adequate bone marrow function independent of blood transfusion or growth factor support per local laboratory reference range at Screening.
* Subjects must have adequate coagulation, renal, and hepatic function, per local laboratory reference range at Screening.
* All acute toxicity from previous anti-tumor treatment or surgery has been alleviated to NCI CTCAE 5.0 ≤ Grade 1.
* All enrolled subjects should take medically approved contraceptives during the entire treatment period and within 90 days after the end of treatment.
* Volunteer and sign informed consent, willing to follow trial protocol.
Exclusion Criteria
* Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of study drug:
* Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy;
* Any investigational treatment;
* Patients who have undergone major surgery, severe trauma or radiotherapy.
* Subjects who have received the following treatments within 1 week before the first dose of study drug:
* Steroids or traditional herbal medicine for antitumor purposes;
* Strong and moderate CYP3A inhibitors and inducers, grapefruit and grapefruit juice;
* Any medications that can cause QTc interval prolongation or torsional tachycardia.
* Solid tumor patients with ITP or AIHA.
* Subjects with known bleeding disease or with a history of non-chemotherapy induced thrombocytopenic bleeding or ineffective platelet transfusion within 1 year before the first dose of study drug.
* Subjects with uncontrollable or CTCAE ≥ grade 2 gastrointestinal bleeding occurred within 90 days before the first dose of study drug.
* Subjects have received the therapeutic dose of anticoagulant or antiplatelet drugs within 1 week before the first dose of study drug.
* Subjects have any serious and/or uncontrolled systemic disease.
* Subjects have poor cardiovascular function, in line with New York Heart Association (NYHA) cardiac function classification ≥ 2 or QTcF greater than 450ms (male) or 470ms (female) on ≥ 3 independent ECG.
* Subjects have disease states where clinical manifestations may be difficult to control, including but not limited to HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
* Lymphoma with primary central nervous system (CNS) malignancy or any disease affects the CNS.
* Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
* Subjects who have known severe allergies to study drugs or any excipients.
* Subjects who have evidence of a second primary tumor.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangzhou Lupeng Pharmaceutical Company 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.
Yilong Wu, MD
Role: STUDY_CHAIR
Guangdong Provincial People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LP-118-CN101
Identifier Type: -
Identifier Source: org_study_id