Actively Recruiting
A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
Led by LaunXP Biomedical Co., Ltd. · Updated on 2025-03-19
24
Participants Needed
2
Research Sites
182 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
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
CONDITIONS
Official 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically or cytologically confirmed advanced solid tumor refractory to current therapies or with no effective treatment.
- Measurable disease according to RECIST 1.1.
- Willingness to provide a tumor biopsy or have a tissue sample from the past 3 years available for analysis.
You will not qualify if you...
- Significant concurrent medical diseases such as congestive heart failure, unstable angina, recent myocardial infarction within 6 months, COPD with frequent exacerbations, uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg), recent cerebrovascular accident within 6 months, or active infection needing intravenous antibiotics.
- Symptomatic, neurologically unstable CNS metastases or requiring increasing steroids; asymptomatic brain metastases must have stable steroid dose for at least 14 days.
- Inadequate bone marrow reserve or organ function including ANC < 1.5 x10^9/L, platelet count < 100 x10^9/L, hemoglobin < 9 g/dL, recent blood transfusion within 2 weeks, elevated bilirubin or liver enzymes above specified limits, or creatinine clearance < 60 mL/min.
- Known HIV-1 or HIV-2 infection.
- Psychiatric disorders that compromise consent or compliance.
- Major surgery within 4 weeks before first dose or ongoing postoperative complications.
- Unresolved toxicities from prior therapies greater than grade 1 except alopecia or skin pigmentation changes.
- Medical conditions that might interfere with study drug administration or interpretation.
- Recent exposure to other investigational or anti-cancer agents within 28 days or 5 half-lives.
- Investigator judgment of inability to comply with study requirements.
- Pregnancy or breastfeeding.
- Unwillingness to use effective contraception if of childbearing potential.
- Positive hepatitis B or hepatitis C test.
- History of allergic reactions to any component of LXP1788 Injection.
AI-Screening
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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
CONTACT
P
Pin-Hung Kuo
CONTACT
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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