80 Participants Needed

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

EL
Overseen ByEric Lynch, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sound Pharmaceuticals, Incorporated
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you've been treated with certain chemotherapy, antibiotics, or diuretics that cause hearing loss in the last 90 days, you cannot participate.

How does this drug differ from other treatments for splicing diseases?

This drug, RECTAS, is unique because it specifically targets and enhances the phosphorylation of splicing factors, which helps correct mis-splicing in genetic diseases like familial dysautonomia. Unlike other treatments, it directly interacts with cellular kinases to modulate splicing, offering a precision medicine approach to splicing disorders.12345

What is the purpose of this trial?

This trial tests SPI-1005, an oral medication, to prevent hearing loss and tinnitus in cancer patients receiving platinum-based chemotherapy. The treatment works by reducing harmful substances that can damage hearing.

Research Team

JK

Jonathan Kil, MD

Principal Investigator

Sound Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion 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
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPI-1005 or placebo orally twice daily for 3 days surrounding each cycle of platinum chemotherapy

Varies with chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • SPI-1005
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: SPI-1005 High DoseActive Control1 Intervention
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group II: SPI-1005 Middle DoseActive Control1 Intervention
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group III: SPI-1005 Low DoseActive Control1 Intervention
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group IV: PlaceboPlacebo Group1 Intervention
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials
14
Recruited
1,300+

VA Puget Sound Health Care System

Collaborator

Trials
67
Recruited
225,000+

References

Major phosphorylation of SF1 on adjacent Ser-Pro motifs enhances interaction with U2AF65. [2018]
Therapeutic manipulation of IKBKAP mis-splicing with a small molecule to cure familial dysautonomia. [2022]
Functional interactions of Prp8 with both splice sites at the spliceosomal catalytic center. [2019]
SR Protein Kinases Regulate the Splicing of Cardiomyopathy-Relevant Genes via Phosphorylation of the RSRSP Stretch in RBM20. [2023]
Conserved loop I of U5 small nuclear RNA is dispensable for both catalytic steps of pre-mRNA splicing in HeLa nuclear extracts. [2021]
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