Overview
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).
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.
Eligibility
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
