A Study of LP-118 in Patients With Advanced Tumors

This is an interventional treatment trial for Solid Tumor Read More

Inclusion Criteria:

• Subjects with histologically or cytologically confirmed malignancy, including either of the following disease: relapsed or refractory lymphomas with at least one measurable disease based on Lugano 2014 criteria; or advanced or metastatic solid tumors 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 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 undergone allogeneic or autologous hematopoietic stem cell transplantation or CAR-T cell therapy (except for lymphoma patients who had received autologous stem cell transplantation or CAR-T cell therapy before 90 days of the first dose of LP-118).

• 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.