drugset / Trial / NCT05570422
A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
NaSingle-groupOpen-labelPrevention
Summary
This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2027-01-30
- Completion
- 2027-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrogen Peroxide | Small molecule | — | Other |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |