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

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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

Other

• 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.

• 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.