Actively Recruiting
A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors
Led by LaunXP Biomedical Co., Ltd. · Updated on 2025-03-19
24
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
L
LaunXP Biomedical Co., Ltd.
Lead Sponsor
E
Efficient Pharma Management Corp.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LXP1788 Injection in a Phase I open-label study for patients with advanced solid tumors that no longer respond to available treatments or have no effective options. The study aims to find the highest dose patients can tolerate and recommend a dose for future studies, while also assessing how the drug behaves in the body and its early effects on tumors. LXP1788 Injection is given intravenously through a port once a week for 60 minutes on days 1, 8, 15, and 22 of each 28-day treatment cycle. The study will determine the maximum tolerated dose and characterize the drug’s plasma pharmacokinetics over two years. Patients will receive treatment in cycles, and the study will monitor safety, tolerability, dose-limiting toxicities, and any anti-tumor activity. Participants will undergo tumor biopsies or provide recent tissue samples for analysis. Regular assessments will include safety monitoring, laboratory tests, and evaluations of tumor response using established criteria. The research team will track adverse events and measure drug exposure levels. Overall participation may last up to two years while closely observing effects and safety.
CONDITIONS
Brief Title
A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Male or female aged 18 years or older.
- Life expectancy greater than 8 weeks.
- ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed advanced solid tumor refractory to current therapies or without effective treatment.
- Measurable disease according to RECIST 1.1 criteria.
- Willingness to provide a recent tumor biopsy or have tissue sample collected within the past 3 years available for analysis.
You will not qualify if you...
- Significant concurrent medical conditions such as congestive heart failure, unstable angina, recent heart attack within 6 months, frequent COPD exacerbations, uncontrolled hypertension, recent stroke within 6 months, or active infection requiring intravenous antibiotics.
- Symptomatic or neurologically unstable brain metastases or requiring increasing steroid doses; asymptomatic brain metastases must be on stable steroid dose less than 14 days before screening.
- Inadequate bone marrow or organ function including low neutrophil count, low platelets, anemia, recent blood transfusion, elevated liver enzymes beyond specified limits, or reduced kidney function (creatinine clearance less than 60 mL/min).
- Known HIV infection.
- Psychiatric disorders affecting compliance or consent ability.
- Major surgery within 4 weeks before first dose or ongoing surgical complications.
- Unresolved toxicities from prior treatments above grade 1 except for hair changes or skin pigmentation.
- Medical conditions that may impair study treatment safety or complicate toxicity assessment.
- Recent exposure to other anticancer agents within 28 days or 5 half-lives.
- Pregnancy or breastfeeding.
- Women or men of childbearing potential not willing to use effective contraception.
- Positive test for hepatitis B or C.
- History of allergic reaction to any component of LXP1788 Injection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive LXP1788 Injection intravenously once a week in a 28-day treatment cycle.
Weekly visits for treatment administration
Trial Site Locations
Total: 2 locations
1
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
2
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
Research Team
C
Chin- Hua Lin Clinical Research Director
P
Pin-Hung Kuo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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