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New treatment option for Solid Tumor Malignancies, Cancer
Official title A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT06883539
What this study is testing
What is LXP1788 is administered intravenously via Port-A?
LXP1788 is administered intravenously via Port-A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor malignancies, cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (\ = 160 mmHg...
- Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of...
- 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
See the full eligibility criteria
- 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.
- Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (\ = 160 mmHg and/or diastolic blood pressure \>= 100 mmHg with or without...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, Taiwan
- Tainan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, Taiwan; Tainan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.