SIR2501 plus Paclitaxel for solid tumors
Official title: A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
Run by Sironax USA, Inc. · NCT07765446 · Data updated 2026-11-12
This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Sironax USA, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Hollywood, Florida and 4 other locations) |
| Status | Recruiting |
| Started | August 21, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07765446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with confirmed solid tumors planned for paclitaxel-based chemotherapy and a good performance status (ECOG 0-2).
✕Probably not a fit
Patients with pre-existing neuropathy, certain medical conditions, prior neurotoxic chemotherapy, or medications that affect CIPN assessment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, open-label trial in adults with solid tumors planned to receive paclitaxel. Participants receive escalating doses of SIR2501 to characterize safety, how the drug behaves in the body, and preliminary signals related to neuropathy. The study aims to see whether SIR2501 can reduce the development or severity of CIPN in this setting. Safety, pharmacokinetics, and neuropathy assessments are collected across sequential cohorts. Locations include multiple US sites, with the lead sponsor being Sironax USA, Inc.
Why it matters
Potential benefit: If successful, SIR2501 could reduce or delay chemotherapy-induced peripheral neuropathy in patients receiving paclitaxel.
How similar studies have gone: Prior similarly designed studies in neuropathy prevention have shown mixed results, making this approach exploratory and novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
- Hollywood, Florida, United States Recruiting
- Baltimore, Maryland, United States Recruiting
- East Brunswick, New Jersey, United States Recruiting
- Boston, Massachusetts, United States Not yet recruiting
- Winston-Salem, North Carolina, United States Not yet recruiting
Study contacts
- Study coordinator: Medical Monitor
- Email: DL-2501-GLB-201-EligibilityReview@Sironax.com
- Phone: +1-617-580-2520
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.