Phase 1 Dose Escalation and Expansion to Evaluate AROG4-01 in Patients With Advanced Solid Tumors

Prior treatment

• Systemic anti-cancer therapy within 4 weeks prior to study admission.
• Radiation therapy within 4 weeks prior to study entry.
• Any major surgery within 4 weeks before first dose of study treatment No major surgery must be planned during the trial expected treatment. receiving study treatment. Participants with recent surgery with only local anesthesia may be included.

Other illness

• Non-malignant systemic disease including cerebrovascular accident, myocardial infarction in the last 6 months, unstable angina pectoris, unstable cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, .
• Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except HbsAc after vaccination) or hepatitis C infection.
• Any other diseases or medical condition that may interfere with the planned treatment, compliance, or place the patient at risk if participating in the study, at investigator criteria.

Lab values

• Left ventricular ejection fraction below institutional normal limits.

Other

• Patients with symptomatic central nervous system (CNS) primary tumor or metastases (including leptomeningeal carcinomatosis). Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.
• Breast feeding, pregnancy or not willing to adopt safe contraceptive measures by the patient or the patient's partner, to become pregnant during treatment or within 6 months after the end of treatment.

• Male or female patients, 18 years or older, with a diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor for which there is no curative therapy, has progressed on SOC treatment or for whom SOC is no longer an option. In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma).
• Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B). Progressive disease to the on or following the last line of antitumor treatment.
• ECOG performance status ≤ 2.
• Life expectancy ≥12 weeks.
• Hematology and clinical chemistry laboratory parameters within acceptable ranges.
• Adequate organ function as defined below:
  • Hemoglobin ≥9 g/dL
  • Neutrophil count ≥1.000x10/mcL
  • Platelets ≥100.000/mcL
  • Total bilirubin ≤1,5 x Upper Limit of Normal (ULN) (unless Gilbert's Disease)
  • AST (SGOT)/ALT (SGPT) ≤ 2,5 x institutional ULN (or ≤ 5X ULN in the presence of liver metastases)
  • Creatinine ≤1.5 mg/dL and creatinine CL ≥40 mL/min (calculated using the Cockcroft-Gault formula)
• Adequate coagulation profile as defined below:
  • INR≤ 1,5
  • aPTT ≤ 1,5 x ULN
  • Serum or urine negative pregnancy test for women with childbearing potential.
• No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days and current adverse events from them ≤ grade 1.