NANOFER-THE-0504: A Trial to Assess the Safety and Tolerability of an Investigational Drug THE-0504 for Patients With Solid Tumors
Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.
• Patients will be enrolled in the study if they meet all the following criteria:
• written informed consent obtained;
• both gender adult (≥ 18 years) patients;
• diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa);
• measurable metastatic disease or locally advanced unresectable tumors;
• have exhausted all EMA-approved treatment options;
• ECOG Performance Status graded as 0 or 1;
• patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;
• adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:
‣ Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis).
⁃ Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor);
• adequate kidney function as assessed by following laboratory test to be conducted within 28 days before the first dose of study treatment:
• • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 according to the CKD-EPI formula.
⁃ adequate bone marrow function as defined as:
∙ Hgb ≥ 9 g/dL
‣ ANC ≥1.5x109/L
‣ PLT≥100.0 x109/L
⁃ Female patients of childbearing potential and male patients who are sexually active with women of childbearing potential will have to mandatorily use an appropriate method of contraception, according to the definition of Note 3 of ICH M3 Guideline, for the entire duration of the trial and for a minimum of 12 months after last administration of the IMP.