KRC-01
Research type
Research Study
Full title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 Intratumoral Injection Combined with Radiotherapy in Patients with Locally Advanced Cervical Cancer
IRAS ID
1008384
Contact name
Kazuyuki Matsuda
Contact email
Sponsor organisation
KORTUC Inc
Eudract number
2022-003021-22
Clinicaltrials.gov Identifier
Research summary
KRC-01 is being developed as a radiosensitizer for the treatment of malignant solid tumors that contain numerous hypoxic cancer cells and/or large quantities of antioxidative enzymes in combination with RT. KRC-01 is a injectable solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer which is the only agent known to be capable of inactivating antioxidative enzymes and producing oxygen simultaneously when applied to tumor tissues. KRC-01 converts hypoxia-induced radioresistant cells such as cervical cancer into radiosensitive cells. Therefore, KRC-01 could overcome radioresistance and to increase efficacy of RT without increasing radiation exposure and side effects to healthy tissue.
This study therefore hopes to discover whether KRC-01 may improve RT therapeutic effect for radical treatment in locally advanced cervical cancer to improve the patient’s long-term outcome.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0175
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion