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

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.