A Study of LP-118 in Patients With Advanced Tumors

Last updated: August 26, 2025
Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neuroblastoma

Treatment

LP-118 tablet

Clinical Study ID

NCT05025358
LP-118-CN101
  • Ages > 18
  • All Genders

Study Summary

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.

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

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: LP-118 tablet
Phase: 1
Study Start date:
September 14, 2021
Estimated Completion Date:
December 30, 2025

Study Description

LP-118 is an oral selective BCL-2 inhibitor with tuned BCL-XL activity, aiming to improve antitumor efficacy and reduce the risk of thrombocytopenia. Clinical development of LP-118 includes targeting of relapsed or refractory hematological malignancies and solid tumors. This is a multi-center, open-label, Phase 1 dose escalation study of LP-118 in patients with advanced malignancies, including advanced/metastatic solid tumors and relapsed/refractory B cell, T/NK cell lymphomas, to determine the safety, tolerability, pharmacokinetics profile and preliminary anti-tumor efficacy. Upon completion of the Phase 1 dose escalation study and establishment of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), the dose expansion study will be implemented in patients with protocol designated type of disease.

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong 510632
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou 1809858, Guangdong 1809935 510632
    China

    Site Not Available

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310006
    China

    Site Not Available

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