SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

Inclusion Criteria:

1. Age ≥ 18 years at the time of signing the ICF.

2. Neoplastic subject that regardless of participation in this study is planned to betreated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m²per cycle and a cumulative dose of cisplatin of at least 210 mg/m².

Exclusion Criteria:

1. Any condition or past medical history that, in the opinion of the Investigator, maycompromise the safety or compliance of the subject or would preclude the subjectfrom successful completion of the study.

2. A congenital or hereditary disease known to decrease hearing function.

3. Any medical history affecting the middle ear function such as chronic otitis,cholesteatoma, or tympanic membrane perforation.

4. Any inner ear disease that is likely to decrease hearing function according to theInvestigator's judgment (e.g, herpes zoster oticus; Meniere's disease; purulentlabyrinthitis; vestibular schwannoma).

5. Having a history of sudden sensory neural hearing loss.

6. Having a fluctuating hearing loss (e.g, due to Meniere's disease, vestibularaqueduct syndrome, or autoimmune inner ear disease).

7. History of head trauma with hearing loss.

8. History of meningitis.

9. Having received concomitant treatment known or suspected to induce an ototoxicitywithin 6 months prior to Screening (i.e, aminoglycosides, loop diuretics, quinine)and any other treatments listed in Appendix 5. Previous treatment with a platinumtreatment should be considered as an exclusion criterion.