NCT06883539

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: LaunXP Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumor Malignancies, Cancer
• Solid Cancers
• Solid Tumor Cancer
• Solid Tumor, Unspecified, Adult
• Solid Tumour
• Solid Tumors Refractory to Standard Therapy
• HCC - Hepatocellular Carcinoma
• RCC, Renal Cell Cancer
• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	LXP1788 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.

Timeline

• Start date: 2024-12-31
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study