RecruitingPhase 1NCT06883539

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

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.


Sponsor

LaunXP Biomedical Co., Ltd.

Enrollment

24 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 safety study of a new experimental cancer drug called LXP1788 in adults with advanced solid tumors (cancers that form a lump, as opposed to blood cancers) that have stopped responding to all available treatments. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor confirmed by biopsy that has not responded to existing treatments - Your cancer can be measured on scans - You are in reasonably good overall health (able to care for yourself) - Your life expectancy is more than 8 weeks - You are willing to have a tumor biopsy or have one available from within the past 3 years **You may NOT be eligible if...** - You have significant heart, lung, kidney, or liver problems - Your cancer has spread to the brain in a way causing active symptoms - You have HIV, active hepatitis B or C - You are pregnant or breastfeeding - You had major surgery within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLXP1788 is administered intravenously via Port-A

LXP1788 Injection is formulated as a solution for injection and will be administered intravenously for 60 minutes on days 1, 8, 15, 22 of the cycle. Each cycle will be 28 days.


Locations(2)

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

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NCT06883539


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