Clinical trial NCT06883539: A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Keywords: Phase 1
LXP1788
LAUNXP
DBPR114-101
solid tumor
cancer
Hepatocellular carcinoma
Pancrease Cancer
Renal Cell Carcinoma
Tyrosine kinase inhibitor
Lead sponsor: LaunXP Biomedical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Efficient Pharma Management Corp.
First posted: 2025-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection
timeFrame: 2 years
measure: To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 Injection
timeFrame: 2 years
Secondary outcomes:
measure: To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
timeFrame: 2 years
measure: To assess exposure levels to LXP1788
timeFrame: 2 years
measure: To assess anti-tumor activity of LXP1788 Injection
timeFrame: 2 years
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: