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NCT Number: NCT07765446

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

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).

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years with confirmed solid tumors
  • Planned treatment with paclitaxel-based chemotherapy
  • ECOG performance status 0-2

Exclusion criteria

  • Pre-existing peripheral neuropathy
  • Conditions or medications that may interfere with neuropathy assessment
  • Prior exposure to neurotoxic chemotherapy
  • Use of medications known to mitigate CIPN
  • Significant medical conditions that may increase study risk

Treatment and study plan

SIR2501

Drug

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 outcomes

  1. Primary Outcome

    Time frame: From first dose through 1 month after last dose

    Incidence of Treatment-Emergent Adverse Events

Secondary outcomes

  1. Secondary Outcome 1 - Pharmacokinetics: Cmax

    Time frame: From first dose through 1 month after last dose

    Maximum Plasma Concentration (Cmax). Cmax of SIR2501 following oral administration

  2. Secondary Outcome 2 - Pharmacokinetics: AUC

    Time frame: From first dose through 1 month after last dose

    Area Under the Plasma Concentration-Time Curve (AUC₀-t). AUC₀-t of SIR2501 following oral administration

  3. Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20

    Time frame: From first dose through 1 month after last dose

    Change from baseline in EORTC QLQ CIPN20 sensory subscale. Patient reported neuropathy symptoms using the validated EORTC QLQ CIPN20 questionnaire

  4. Secondary Outcome 4 - Neuropathy: TNS/TNSc

    Time frame: From first dose through 1 month after last dose

    Change from baseline in Total Neuropathy Score/Clinical Version (TNS/TNSc). Clinician rated neuropathy severity using TNS/TNSc

  5. Secondary Outcome 6 - Neuropathy:

    Time frame: From first dose through 1 month after last dose

    NCI CTCAE Grade NCI CTCAE v5.0 grade for CIPN. Clinician graded peripheral neuropathy severity

  6. Secondary Outcome 7 - Pharmacodynamics: NfL

    Time frame: From first dose through 1 month after last dose

    Change from baseline in blood neurofilament light chain (NfL) Description: Plasma NfL concentration measured by validated immunoassay

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

+1-617-580-2520

Sponsors and collaborators

Lead sponsor

Sironax USA, Inc.

Industry

Registry information

Official study title

A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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