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NCT07765446PHASE2Recruiting

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

Sironax USA, Inc.

Start Date

8/21/2026

Completion Date

12/31/2027

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).

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

SIR2501

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Conditions

Chemotherapy-induced Peripheral Neuropathy

Locations

Hollywood, Florida 33024

United States

Baltimore, Maryland 21287

United States

East Brunswick, New Jersey 08816

United States