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DB-020

Phase 1

Ototoxicity | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 6, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04262336Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer TreatmentPHASE1 COMPLETED 22 — — Feb 21, 2020May 23, 2023Jul 6, 20238 United States, Australia
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Study Endpoints
Primary Endpoints
Number of patients with treatment-emergent Adverse Events (TEAEs) and/or abnormal changes from baseline in clinical laboratory abnormalities and/or vital signs and/or ECG assessments
From screening/baseline (Day -28 to Day -2) or day of first dose of DB-020 (Cycle 1 Day 1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug

To investigate the safety and tolerability of DB-020 when given intratympanically to patients receiving cisplatin chemotherapy treatment

Secondary Endpoints
Incidence of Ototoxicity measured by American Speech-Language-Hearing Association (ASHA) criteria
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
Changes from Baseline in Pure Tone Threshold Values compared to End of Treatment [Changes in Hearing]
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
Changes from Baseline in Tinnitus Functional Index (TFI) Total Score compared to End of Treatment [Changes in Hearing]
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
DB-020 for Injection, 12%/placeboACTIVE_COMPARATORdosage
DB-020 for Injection, 25%/placeboACTIVE_COMPARATORdosage
Interventions
NameTypeDescription
DB-020DRUGInjectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water
PlaceboDRUGInjectable sterile viscous solution of sodium hyaluronate in sodium chloride
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Ability to communicate with medical team and staff, willingness to participate in the study, give written informed consent, comply with the study restrictions * Adults aged 18 years, inclusive, or older * Treatment for cancer with Intervenous cisplatin once every 21 or 28 days...

Countries:United StatesAustralia
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