SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Study summary

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSPI-1005 Low Dose and SPI-1005 Middle Dose

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sound Pharmaceuticals, Incorporated

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Sound Pharmaceuticals, Incorporated
Interventions being studied: Drug: SPI-1005 Low Dose; Drug: SPI-1005 Middle Dose; Drug: SPI-1005 High Dose; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Adult male and female subjects, 19-80 years of age;
Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
Voluntarily consent to participate in the study
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
IUD in place for at least 3 months prior to study;
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Reasons someone may not be able to joinExclusion criteria

Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
Presence of alcoholism or drug abuse
Participation in another investigational drug or device clinical trial within 30 days prior to the study
Female subjects who are pregnant or lactating

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

VA Puget Sound Health CareSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 3, 2026. Always confirm current availability with the study team.

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