Status:
RECRUITING
A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
Lead Sponsor:
LaunXP Biomedical Co., Ltd.
Collaborating Sponsors:
Efficient Pharma Management Corp.
Conditions:
Solid Tumor Malignancies, Cancer
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Inje...
Eligibility Criteria
Inclusion
- Written (signed) Informed Consent.
- Male or female ≥ 18 years old.
- Life expectancy \> 8 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.
- Measurable disease per RECIST 1.1.
- 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
- 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.
- 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.
- 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
- Known history of human immunodeficiency virus (HIV)-1 or -2 infection.
- Psychiatric disorders that would compromise the patient's compliance or ability to give consent.
- Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.
- 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.
- 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.
- 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.
- 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.
- Pregnancy or breast feeding.
- Women or men of childbearing potential not willing to use effective means of contraception.
- Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).
- History of allergic reactions to any component of LXP1788 Injection.
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06883539
Start Date
December 31 2024
End Date
June 30 2028
Last Update
March 19 2025
Active Locations (2)
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1
China Medical University Hospital
Taichung, Taiwan, 404
2
National Cheng Kung University Hospital
Tainan, Taiwan, 704