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

Ki vehet részt

• 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

Ki nem vehet részt

• 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
• 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
• 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
• 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
• 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
• 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
• 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