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

2026-09-01

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

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 (2)

Facility	City	Region	Status
—	Baltimore	Maryland	Recruiting
—	East Brunswick	New Jersey	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