A Study of LP-118 in Patients With Advanced Tumors

NCT05025358 | Completed Phase 1 FDA Drug

• 1 other identifier: LP-118-CN101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Solid Tumor; Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (6)

• Maximum tolerated dose (MTD)

  The highest dose that does not cause unacceptable side effects or overt toxicities which will be assessed by NCI CTCAE v5.0.

  Up to 24 months

• Adverse events

  The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.

  Up to 24 months

• Recommended phase II dose (RP2D)

  The safe dose that demonstrates the greatest pharmacological activity.

  Up to 24 months

• PK evaluation of area under the plasma concentration versus time curve (AUC) of LP-118

  AUC indicates the extent of exposure to LP-118 and its clearance rate from the body.

  Up to Cycle 6 (each cycle is 28 days)

• PK evaluation of peak plasma concentration (Cmax) of LP-118

  Cmax indicates the highest drug concentration in the blood after LP-118 administration.

  Up to Cycle 6 (each cycle is 28 days)

• PK evaluation of time to maximum concentration (Tmax) of LP-118

  Tmax indicates the time taken to reach the maximum drug concentration (i.e. Cmax).

  Up to Cycle 6 (each cycle is 28 days)

Secondary Outcomes (4)

• Overall response rate (ORR)

  Up to 24 months

• Duration of response (DOR)

  Up to 24 months

• Progression-free survival (PFS)

  Up to 24 months

• Overall survival

  Up to 24 months

Study Arms (1)

LP-118

EXPERIMENTAL

The classic "3+3" design at dose levels of 50mg, 100mg, 200mg, 300mg, 400mg and 500mg will be implemented in this study.

Drug: LP-118 tablet

Interventions

LP-118 tablet DRUG

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.

Also known as: NWP-4-76

LP-118

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (4)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

Location

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

Wuhan, Hubei, 430022, China

Location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 27, 2021
• Study Start: September 8, 2021
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)