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Clinical Trial Record

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A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.

2024-12-31

2027-12-31

2028-06-30

24

Study Overview

A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.

A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor. Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected. The main questions it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection 2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection

N/A

  • Solid Tumor Malignancies, Cancer
  • Solid Cancers
  • Solid Tumor Cancer
  • Solid Tumor, Unspecified, Adult
  • Solid Tumour
  • Solid Tumors Refractory to Standard Therapy
  • HCC - Hepatocellular Carcinoma
  • RCC, Renal Cell Cancer
  • Pancreas Cancer
  • DRUG: LXP1788 is administered intravenously via Port-A
  • DBPR114-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-03-06  

N/A  

2025-03-12  

2025-03-12  

N/A  

2025-03-19  

2025-03-19  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle.

DRUG: LXP1788 is administered intravenously via Port-A

  • LXP1788 Injection is formulated as a solution for injection and will be administered intravenously for 60 minutes on days 1, 8, 15, 22 of the cycle. Each cycle will be 28 days.
Primary Outcome MeasuresMeasure DescriptionTime Frame
To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection2 years
To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 InjectionPK blood samples to determine plasma concentrations of LXP1788 will be collected at the time points listed in the schedule of events table. Where possible, the plasma concentration-time data will be used to calculate the following parameters for LXP1788 Injection by non-compartmental methods: Maximum plasma concentration (Cmax), dose-normalized Cmax (Cmax/D), area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), dose-normalized AUC0-24 (AUC0-24/D), AUC from time 0 to the last quantifiable concentration (AUC0-last), dose-normalized AUC0-last (AUC0-last/D), AUC from time 0 extrapolated to infinity (AUC0-inf), dose-normalized AUC0-inf (AUC0-inf/D), time to Cmax (tmax), plasma clearance (CL), volume of distribution (Vz), terminal rate constant (λz), and terminal elimination half-life (t1/2).2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 InjectionTo assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection2 years
To assess exposure levels to LXP1788To assess exposure levels to LXP17882 years
To assess anti-tumor activity of LXP1788 InjectionTo assess anti-tumor activity of LXP1788 Injection * Objective response rate (ORR) using RECIST 1.1 for solid tumor * Time to tumor progression (TTP) * Disease control rate (DCR) * Clinical benefit rate (CBR) * Duration of response (DoR) * Progression free survival (PFS)2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chin- Hua Lin Clinical Research Director

Phone Number: +886-4-2320-5691

Email: rdjulialin@launxp.com

Study Contact Backup

Name: Pin-Hung Kuo

Phone Number: +886-4-2320-5691

Email: phkuo@launxp.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Written (signed) Informed Consent. 2. Male or female ≥ 18 years old. 3. Life expectancy > 8 weeks. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available. 6. Measurable disease per RECIST 1.1. 7. Willing to have a tumor biopsy or having tissue sample from a previous biopsy available in the tissue bank for analysis that had been collected in the past 3 years.
    Exclusion Criteria:
    1. Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (< 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg with or without anti-hypertensive medication), recent CVA (< 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics. 2. Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.
    Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening. 3. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
    Bone marrow:
  • Absolute neutrophil count (ANC) < 1.5 x 10^9/L
  • Platelet count < 100 x 10^9/L
  • Hemoglobin < 9 g/dL
  • Having had a blood transfusion within 2 weeks of screening date is also not allowed.

    • Hepatic:
  • Total bilirubin > 1.5 x ULN
  • AST and ALT > 3 x ULN if no liver metastases
  • AST and ALT > 5 x ULN in the presence of liver metastases

    • Renal:
    ⚫ Estimated creatinine clearance (CrCL) < 60 mL/min per the Cockcroft and Gault formula 4. Known history of human immunodeficiency virus (HIV)-1 or -2 infection. 5. Psychiatric disorders that would compromise the patient's compliance or ability to give consent. 6. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications. 7. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation. 8. Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events. 9. Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator. 10. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements. 11. Pregnancy or breast feeding. 12. Women or men of childbearing potential not willing to use effective means of contraception. 13. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA). 14. History of allergic reactions to any component of LXP1788 Injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Efficient Pharma Management Corp.
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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