This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan. Cisplatin treatment per chemotherapy protocol must be given at a cumulative dose high enough to significantly increase the iatrogenic likelihood of ototoxicity (unit cisplatin dose of at least 70 mg/m2 and cumulative cisplatin dose of at least 210 mg/m²). If all the eligibility criteria are met, subjects will be randomized to one of two study arms as follows:

• Arm A (control arm): Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.
• Arm B: Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.

All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.

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 be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m² per 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, may compromise the safety or compliance of the subject or would preclude the subject from 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 the Investigator's judgment (e.g, herpes zoster oticus; Meniere's disease; purulent labyrinthitis; 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, vestibular aqueduct 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 ototoxicity within 6 months prior to Screening (i.e, aminoglycosides, loop diuretics, quinine) and any other treatments listed in Appendix 5. Previous treatment with a platinum treatment should be considered as an exclusion criterion.

The Full Analysis Set (FAS) included all randomized participants. One (1) participant randomized in Arm B was excluded from the FAS due to failure to take at least one dose of SENS-401 and the lack of any data post randomization. Twenty three (23) participants who received at least one dose of SENS-401 and all twenty four (24) participants randomized to control arm, were included in the FAS.

From enrollment until end of follow-up (up to 31 weeks)

Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment.

Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).