Clinical trial · Interventional
A Study of LP-118 in Patients With Advanced Tumors
A Phase I Study on Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of LP-118 in Patients With Advanced Malignancies
NCT05025358CI-TRIAL-00099693completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I, multi-center, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-118 in patients with advanced malignancies, including solid tumors and lymphomas. LP-118 is a BCL-2/BCL-XL small molecule inhibitor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LP-118 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LP-118
- description
- The classic "3+3" design at dose levels of 50mg, 100mg, 200mg, 300mg, 400mg and 500mg will be implemented in this study.
- interventionNames
- Drug: LP-118 tablet
Primary outcomes (6)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to 24 months
- description
- The highest dose that does not cause unacceptable side effects or overt toxicities which will be assessed by NCI CTCAE v5.0.
- measure
- Adverse events
- timeFrame
- Up to 24 months
- description
- The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.