A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)

Exclusion Criteria

• •1. Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than five half-lives from a small molecule targeted therapy or oral anticancer chemotherapy before the first IMP administration
• •2. Any immunotherapy within preceding 6 weeks from the first IMP administration
• •3. Investigational therapy or major surgery within 4 weeks from the date of consent
• •4. Active clinically serious infection \> Grade 2 NCI-CTCAE version 5.0 (Appendix 5 - Common Toxicity Criteria Gradings) within preceding 2 weeks from the date of consent
• •5. Brain metastases
• •6. Subject has not recovered from the previous therapies to Grade ≤ 1 severity as classified by the NCI-CTCAE version 5.0 (except Grade ≤ 2 alopecia, neuropathy or thyroid disorders)
• •7. Pregnant or lactating women
• •8. History of second malignancy except for non-melanotic skin cancer, cervical carcinoma in situ or superficial bladder cancer, or any other malignancy treated previously with curative intent and more than three years without relapse
• •9. Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2 (Appendix 7 - NYHA classification), Myocardial Infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the subject to participate in the trial
• •10. Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment
• •11. Confirmed human immunodeficiency virus infection
• •12. Symptomatic cytomegalovirus infection
• •13. Subjects with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia)
• •14. The subject requires systemic corticosteroid or other immunosuppressive treatment
• •15. Subjects with organ transplants
• •16. Subjects in dialysis
• •17. Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit
• •18. Subject is unwilling or unable to comply with treatment and trial instructions
• •19. Subjects with known hypersensitivity to the IMP or any of the pharmaceutical ingredients
• •1. Any ablative therapy (Radio Frequency Ablation or Percutaneous Ethanol Injection) for HCC (this should not exclude subjects if target lesion(s) have not been treated and occurred \> 6 weeks prior trial entry)
• •2. Hepatic encephalopathy
• •3. Ascites refractory to diuretic therapy
• •4. Child-Pugh score ≥ 7