Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sironax USA, Inc.
Study ID
NCT07765446
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

First listed
Aug 14, 2026
Start date
Aug 21, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: 30 mg
  • Experimental: 45 mg
  • Experimental: 60 mg

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
-BaltimoreMaryland21287-
-East BrunswickNew Jersey08816-

Related Studies