Phase
Condition
Neuroblastoma
Treatment
LP-118 tablet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with histologically or cytologically confirmed malignancy, including eitherof the following disease: relapsed or refractory lymphomas with at least onemeasurable disease based on Lugano 2014 criteria; or advanced or metastatic solidtumors based on RECIST V1.1 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 orgrowth factor support per local laboratory reference range at Screening.
Subjects must have adequate coagulation, renal, and hepatic function, per locallaboratory reference range at Screening.
All acute toxicity from previous anti-tumor treatment or surgery has been alleviatedto NCI CTCAE 5.0 ≤ Grade 1.
All enrolled subjects should take medically approved contraceptives during theentire treatment period and within 90 days after the end of treatment.
Volunteer and sign informed consent, willing to follow trial protocol.
Exclusion
Exclusion Criteria:
Subjects who have undergone allogeneic or autologous hematopoietic stem celltransplantation or CAR-T cell therapy (except for lymphoma patients who had receivedautologous stem cell transplantation or CAR-T cell therapy before 90 days of thefirst dose of LP-118).
Subjects who have received the following treatments within 4 weeks or 5 half-livesbefore 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 firstdose of study drug:
Steroids or traditional herbal medicine for antitumor purposes;
Strong and moderate CYP3A inhibitors and inducers, grapefruit and grapefruitjuice;
Any medications that can cause QTc interval prolongation or torsionaltachycardia.
Solid tumor patients with ITP or AIHA.
Subjects with known bleeding disease or with a history of non-chemotherapy inducedthrombocytopenic bleeding or ineffective platelet transfusion within 1 year beforethe first dose of study drug.
Subjects with uncontrollable or CTCAE ≥ grade 2 gastrointestinal bleeding occurredwithin 90 days before the first dose of study drug.
Subjects have received the therapeutic dose of anticoagulant or antiplatelet drugswithin 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 tocontrol, including but not limited to HIV, HBV, HCV, syphilis positive or activebacterial and fungal infections.
Lymphoma with primary central nervous system (CNS) malignancy or any disease affectsthe CNS.
Any gastrointestinal conditions that may severely affect the study drug absorptionor pharmacokinetic parameters.
Subjects who have known severe allergies to study drugs or any excipients.
Subjects who have evidence of a second primary tumor.
Study Design
Study Description
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong 510632
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
The First Affiliated Hospital of Jinan University
Guangzhou 1809858, Guangdong 1809935 510632
ChinaSite Not Available
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430022
ChinaSite Not Available
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310006
ChinaSite Not Available
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310006
ChinaSite Not Available

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