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RECRUITING
NCT07765446
PHASE2

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

Sponsor: Sironax USA, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-08-21

Completion Date

2027-12-31

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (3)

Hollywood, Florida, United States

Baltimore, Maryland, United States

East Brunswick, New Jersey, United States