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

NCT06883539 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Efficient Pharma Management Corp.

    collaborator INDUSTRY

  • LaunXP Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883539 on ClinicalTrials.gov