RECRUITING Phase 2 ClinicalTrials.gov

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

Sponsor: Sironax USA, Inc. • ClinicalTrials.gov ID: NCT07765446

Registry updated: 2026-10-09

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Description

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).

Interventions

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.

Eligibility criteria

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

Conditions

Chemotherapy-induced Peripheral Neuropathy

Locations

Hollywood, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
East Brunswick, New Jersey, United States
Winston-Salem, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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