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Solid TumorPhase 1NCT05025358

A Study of LP-118 in Patients With Advanced Tumors

A Phase 1 study testing LP-118 tablet in people with Solid Tumor and Lymphoma, Non-Hodgkin, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Lymphoma, Non-Hodgkin
What is being tested?
LP-118 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
4 sitesChina
Study dates
8 Sep 2021to 9 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510632

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006

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

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: A Phase I Study on Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of LP-118 in Patients With Advanced Malignancies

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.

Read the detailed 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.

Being tested
LP-118 tablet
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP-118 tabletDrug

    Also called NWP-4-76

    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.

Study groups in NCT05025358
Study groupRoleWhat they receive
LP-118ExperimentalThe classic "3+3" design at dose levels of 50mg, 100mg, 200mg, 300mg, 400mg and 500mg will be implemented in this study.
Receives: Drug: LP-118 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

  2. Adverse events

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

    Measured: Up to 24 months

  3. Recommended phase II dose (RP2D)

    The safe dose that demonstrates the greatest pharmacological activity.

    Measured: Up to 24 months

  4. 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.

    Measured: Up to Cycle 6 (each cycle is 28 days)

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

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

    Measured: Up to Cycle 6 (each cycle is 28 days)

  6. 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).

    Measured: Up to Cycle 6 (each cycle is 28 days)

Secondary outcomes (4)

  1. Overall response rate (ORR)

    The proportion of patients who have a partial or complete response after LP-118 treatment.

    Measured: Up to 24 months

  2. Duration of response (DOR)

    The time from first documented response to disease progression or death.

    Measured: Up to 24 months

  3. Progression-free survival (PFS)

    The time from first dose to disease progression or death, whichever occurs first.

    Measured: Up to 24 months

  4. Overall survival

    The time from first dose to the date of death from any cause.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start8 Sep 2021
  3. Primary completion9 Jul 2025
  4. Study completion9 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025358
Sponsor's protocol ID
LP-118-CN101
Status last verified
Dec 2025
First submitted
30 Jul 2021
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LP-118 tablet in people with Solid Tumor and Lymphoma, Non-Hodgkin, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: Up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05025358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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