Recruiting
Phase 2

SIR2501 with Paclitaxel

Sponsor:

Sironax USA, Inc.

Code:

NCT07765446

Conditions

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SIR2501

Study Details

Brief 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).

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT07765446

Start date

Aug 21, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 30 mg

experimental: 45 mg

experimental: 60 mg

Interventions

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.

Primary outcome measure

  • Primary Outcome [ Time Frame: From first dose through 1 month after last dose ]

Central Contacts and Locations

Central contacts

Medical Monitor

+1-617-580-2520DL-2501-GLB-201-EligibilityReview@Sironax.com

Locations

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Sironax USA, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • CIPN
  • Paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sironax USA, Inc. on 2026-09-01.