A Phase 2 interventional study of SIR2501 in Chemotherapy-induced Peripheral Neuropathy, sponsored by Sironax USA, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Sironax USA, Inc. · Phase 2, Interventional, and Prevention
This Phase 2, open-label study will evaluate the safety, tolerability, and pharmacokinetics of SIR2501 in adults with solid tumors who are scheduled to receive paclitaxel-based chemotherapy. The study will also explore whether SIR2501 has the potential to reduce the development of chemotherapy-induced peripheral neuropathy (CIPN).
SIR2501 will be administered to sequential cohorts at increasing dose levels. The study will characterize safety, pharmacokinetics, and preliminary signals related to neuropathy assessment in patients receiving paclitaxel.
Exclusion Criteria:
Drug: SIR2501
Drug: SIR2501
Drug: SIR2501
Experimental: 30 mg SIR2501 administered at 30 mg dose level. Experimental: 45 mg SIR2501 administered at 45 mg dose level. Experimental: 60 mg SIR2501 administered at 60 mg dose level.
Primary Outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose through 1 month after last dose
Secondary Outcome 1 - Pharmacokinetics: Cmax
Maximum Plasma Concentration (Cmax). Cmax of SIR2501 following oral administration
Time frame: From first dose through 1 month after last dose
Secondary Outcome 2 - Pharmacokinetics: AUC
Area Under the Plasma Concentration-Time Curve (AUC₀-t). AUC₀-t of SIR2501 following oral administration
Time frame: From first dose through 1 month after last dose
Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20
Change from baseline in EORTC QLQ CIPN20 sensory subscale. Patient reported neuropathy symptoms using the validated EORTC QLQ CIPN20 questionnaire
Time frame: From first dose through 1 month after last dose
Secondary Outcome 4 - Neuropathy: TNS/TNSc
Change from baseline in Total Neuropathy Score/Clinical Version (TNS/TNSc). Clinician rated neuropathy severity using TNS/TNSc
Time frame: From first dose through 1 month after last dose
Secondary Outcome 6 - Neuropathy:
NCI CTCAE Grade NCI CTCAE v5.0 grade for CIPN. Clinician graded peripheral neuropathy severity
Time frame: From first dose through 1 month after last dose
Secondary Outcome 7 - Pharmacodynamics: NfL
Change from baseline in blood neurofilament light chain (NfL) Description: Plasma NfL concentration measured by validated immunoassay
Time frame: From first dose through 1 month after last dose
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Sironax USA, Inc.