Clinical Trials List
Protocol NumberDBPR114-101
NCT Number(ClinicalTrials.gov Identfier)NCT06883539
Active
2024-03-13 - 2028-03-13
Phase I
Recruiting2
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.
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ching Yun Hsieh Division of Hematology & Oncology
- 陳珈妤 Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
- Shang-Hung Chen Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- 黃盈慈 Division of Hematology & Oncology
- 蘇勇曄 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Solid Tumor Malignancies, Cancer
Objectives
Primary Objectives:
1. To determine the maximum tolerated dose (MTD) of LXP1788 injection and establish the recommended drug dose (RP2D) for phase II clinical trials.
2. To investigate the pharmacokinetics of LXP1788 injection.
Secondary Objectives:
1. To evaluate the safety and tolerability of LXP1788 injection.
2. To preliminarily assess the anticancer efficacy of LXP1788 injection.
Exploratory Objectives: To evaluate the correlation between biomarkers and antitumor activity.
Test Drug
注射劑
Active Ingredient
LXP1788
Dosage Form
270
Dosage
25 mg/5 mL
Endpoints
1. Key Assessment Indicators:
(1) Determine the maximum tolerated dose (MTD) of LXP1788 injection and establish the recommended drug dose and duration of treatment (RP2D) for a phase II clinical trial.
(2) Investigate the pharmacokinetic characteristics of LXP1788 in plasma after injection.
(1) Determine the maximum tolerated dose (MTD) of LXP1788 injection and establish the recommended drug dose and duration of treatment (RP2D) for a phase II clinical trial.
(2) Investigate the pharmacokinetic characteristics of LXP1788 in plasma after injection.
Inclution Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
Exclusion Criteria:
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
Known history of human immunodeficiency virus (HIV)-1 or -2 infection.
Psychiatric disorders that would compromise the patient's compliance or ability to give consent.
Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.
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.
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.
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.
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.
Pregnancy or breast feeding.
Women or men of childbearing potential not willing to use effective means of contraception.
Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).
History of allergic reactions to any component of LXP1788 Injection.
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
Known history of human immunodeficiency virus (HIV)-1 or -2 infection.
Psychiatric disorders that would compromise the patient's compliance or ability to give consent.
Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.
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.
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.
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.
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.
Pregnancy or breast feeding.
Women or men of childbearing potential not willing to use effective means of contraception.
Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).
History of allergic reactions to any component of LXP1788 Injection.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
24 participants
