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

Phase 1

Recruiting

• 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

• Registration Number: NCT06883539
• Lead Sponsor: LaunXP Biomedical Co., Ltd.

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. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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:

   • 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

4. Known history of human immunodeficiency virus (HIV)-1 or -2 infection.

5. Psychiatric disorders that would compromise the patient's compliance or ability to give consent.

6. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.

7. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation.

8. Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events.

9. Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator.

10. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements.

11. Pregnancy or breast feeding.

12. Women or men of childbearing potential not willing to use effective means of contraception.

13. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).

14. History of allergic reactions to any component of LXP1788 Injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle.	LXP1788 is administered intravenously via Port-A	-

Primary Outcome Measures

Name	Time	Method
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	2 years	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).

Secondary Outcome Measures

Name	Time	Method
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection	2 years	To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
To assess exposure levels to LXP1788	2 years	To assess exposure levels to LXP1788
To assess anti-tumor activity of LXP1788 Injection	2 years	To assess anti-tumor activity of LXP1788 Injection; * Objective response rate (ORR) using RECIST 1.1 for solid tumor; * Time to tumor progression (TTP); * Disease control rate (DCR); * Clinical benefit rate (CBR); * Duration of response (DoR); * Progression free survival (PFS)

Trial Locations

Locations (2)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan