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Clinical Trials in the USA / NCT07765446
Recruiting Phase 2

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

NCT07765446 · tracked via the Priya Life Science USA tracker
Sponsor
Sironax USA, Inc
Phase
Phase 2
Started
2026-08-21
Last updated
2026-10-09

Condition(s) studied

Chemotherapy-induced Peripheral Neuropathy

Investigational drug(s) / intervention(s)

SIR2501

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Primary Outcome — From first dose through 1 month after last dose
    Incidence of Treatment-Emergent Adverse Events

Trial sites (5)

FacilityCityRegionStatus
— Hollywood Florida Recruiting
— Baltimore Maryland Recruiting
— Boston Massachusetts Not Yet Recruiting
— East Brunswick New Jersey Recruiting
— Winston-Salem North Carolina Not Yet Recruiting

Other trials for the same condition

Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07765446 on ClinicalTrials.gov ↗ ← All trials in the USA