NCT06883539

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 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. 1.To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection
  2. 2.To evaluate the pharmacokinetics (PK) of LXP1788 Injection

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
27mo left

Started Dec 2024

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Dec 2024Jun 2028

Study Start

First participant enrolled

December 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 6, 2025

Last Update Submit

March 12, 2025

Conditions

Solid Tumor Malignancies, CancerSolid CancersSolid Tumor CancerSolid Tumor, Unspecified, AdultSolid TumourSolid Tumors Refractory to Standard TherapyHCC - Hepatocellular CarcinomaRCC, Renal Cell CancerPancreas Cancer

Keywords

Phase 1LXP1788LAUNXPDBPR114-101solid tumorcancerHepatocellular carcinomaPancrease CancerRenal Cell CarcinomaTyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (2)

  • To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection

    2 years

  • To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 Injection

    PK blood samples to determine plasma concentrations of LXP1788 will be collected at the time points listed in the schedule of events table. Where possible, the plasma concentration-time data will be used to calculate the following parameters for LXP1788 Injection by non-compartmental methods: Maximum plasma concentration (Cmax), dose-normalized Cmax (Cmax/D), area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), dose-normalized AUC0-24 (AUC0-24/D), AUC from time 0 to the last quantifiable concentration (AUC0-last), dose-normalized AUC0-last (AUC0-last/D), AUC from time 0 extrapolated to infinity (AUC0-inf), dose-normalized AUC0-inf (AUC0-inf/D), time to Cmax (tmax), plasma clearance (CL), volume of distribution (Vz), terminal rate constant (λz), and terminal elimination half-life (t1/2).

    2 years

Secondary Outcomes (3)

  • To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection

    2 years

  • To assess exposure levels to LXP1788

    2 years

  • To assess anti-tumor activity of LXP1788 Injection

    2 years

Study Arms (1)

LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle.

EXPERIMENTAL
Drug: LXP1788 is administered intravenously via Port-A

Interventions

LXP1788 is administered intravenously via Port-ADRUG

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.

LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

NeoplasmsCarcinoma, HepatocellularCarcinoma, Renal CellPancreatic Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Chin- Hua Lin Clinical Research Director

CONTACT

+886-4-2320-5691rdjulialin@launxp.com

Pin-Hung Kuo

CONTACT

+886-4-2320-5691phkuo@launxp.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 19, 2025

Study Start

December 31, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)