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A Phase I Study of LXP1788 Injection with Advanced Solid Tumors. | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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.

NCT06883539•LaunXP Biomedical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written (signed) Informed Consent.
•2. Male or female ≥ 18 years old.
•3. Life expectancy \> 8 weeks.
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•5. A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.
•6. Measurable disease per RECIST 1.1.
•7. 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.

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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:
+16 more criteria

Locations (2)

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Key Dates

Start Date

December 31, 2024

Primary Completion Date

December 31, 2027

Completion Date

June 30, 2028

Last Updated

March 19, 2025

Enrollment

ESTIMATED participants

Conditions

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

Interventions

LXP1788 is administered intravenously via Port-A

DRUG

Contacts

Chin- Hua Lin Clinical Research Director

CONTACT

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

Pin-Hung Kuo

CONTACT

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

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

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Advanced Solid Tumor Cancer

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A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

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