Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel

A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07765446

Enrollment

Registered

2026-08-14

Start date

2026-08-21

Completion date

2027-12-31

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

CIPN, Paclitaxel

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).

Detailed description

SIR2501 will be administered to sequential cohorts at increasing dose levels. The study will characterize safety, pharmacokinetics, and preliminary signals related to neuropathy assessment in patients receiving paclitaxel.

Interventions

DRUGSIR2501

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 design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome	From first dose through 1 month after last dose	Incidence of Treatment-Emergent Adverse Events

Secondary

Measure	Time frame	Description
Secondary Outcome 1 - Pharmacokinetics: Cmax	From first dose through 1 month after last dose	Maximum Plasma Concentration (Cmax). Cmax of SIR2501 following oral administration
Secondary Outcome 2 - Pharmacokinetics: AUC	From first dose through 1 month after last dose	Area Under the Plasma Concentration-Time Curve (AUC₀-t). AUC₀-t of SIR2501 following oral administration
Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20	From first dose through 1 month after last dose	Change from baseline in EORTC QLQ CIPN20 sensory subscale. Patient reported neuropathy symptoms using the validated EORTC QLQ CIPN20 questionnaire
Secondary Outcome 4 - Neuropathy: TNS/TNSc	From first dose through 1 month after last dose	Change from baseline in Total Neuropathy Score/Clinical Version (TNS/TNSc). Clinician rated neuropathy severity using TNS/TNSc
Secondary Outcome 6 - Neuropathy:	From first dose through 1 month after last dose	NCI CTCAE Grade NCI CTCAE v5.0 grade for CIPN. Clinician graded peripheral neuropathy severity
Secondary Outcome 7 - Pharmacodynamics: NfL	From first dose through 1 month after last dose	Change from baseline in blood neurofilament light chain (NfL) Description: Plasma NfL concentration measured by validated immunoassay

Countries

United States

Contacts

CONTACTMedical Monitor

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026