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

Last updated: March 12, 2025
Sponsor: LaunXP Biomedical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Pancreatic Cancer

Neoplasms

Treatment

LXP1788 is administered intravenously via Port-A

Clinical Study ID

NCT06883539
DBPR114-101
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 refractoryto 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 biopsyavailable in the tissue bank for analysis that had been collected in the past 3years.

Exclusion

Exclusion Criteria:

  1. Significant concurrent medical diseases, such as congestive heart failure, unstableangina, acute or recent myocardial infarction (< 6 months before enrollment), COPDwith frequent exacerbations, uncontrolled hypertension (systemic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg with or withoutanti-hypertensive medication), recent CVA (< 6 months before enrollment), or activeinfection which requires treatment withintravenous antibiotics.

  2. Patients with symptomatic CNS metastases who are neurologically unstable, receivingradiotherapy for the CNS lesion, or requiring increasing dose of steroids to controltheir CNS disease. Asymptomatic patients with metastatic brain disease who have been on a stable doseof steroids for less than 14 days prior to screening.

  3. Inadequate bone marrow reserve or organ function as demonstrated by any of thefollowing 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 notallowed. 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 Gaultformula

  1. Known history of human immunodeficiency virus (HIV)-1 or -2 infection.

  2. Psychiatric disorders that would compromise the patient's compliance or ability togive consent.

  3. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection orwith ongoing postoperative complications.

  4. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve tograde 0 or 1 as per the National Cancer Institute (NCI) - Common TerminologyCriteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia,skin hyperpigmentation or hypopigmentation.

  5. Underlying medical conditions that, in the investigator's opinion, will make theadministration of LXP1788 Injection hazardous or obscure the interpretation oftoxicities or adverse events.

  6. Exposure to any other investigational or commercial anti-cancer agents or curativetherapies within 28 days or 5 half-lives (whichever is shorter), before the firstdose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposesor pain control may be permitted under the judgement of the investigator.

  7. Judgment by the investigator that the patient should not participate in the studybecause the patient is unlikely to comply with study procedures, restrictions, orrequirements.

  8. Pregnancy or breast feeding.

  9. Women or men of childbearing potential not willing to use effective means ofcontraception.

  10. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody withdetectable HCV RNA).

  11. History of allergic reactions to any component of LXP1788 Injection.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: LXP1788 is administered intravenously via Port-A
Phase: 1
Study Start date:
December 31, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

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