hydrogen peroxide (KRC-01) / Kortuc - LARVOL DELTA

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer (clinicaltrials.gov) - P2 | N=184 | Active, not recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

2025/4237 K-BOOST: Phase II Clinical Trial of KORTUC (KRC-01) Combined with Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach (K-BOOST) (clinicaltrialsregister.eu) - P1/2 | N=24 | Not yet recruiting | Sponsor: Institut Gustave Roussy

New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

K-BOOST: KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

New P2 trial • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Exploring the role of hydrogen peroxide in the immune microenvironment of hypoxic tumors. (PubMed, Clin Transl Radiat Oncol) - "H2O2 promotes immunogenic cell death, preserves T cell function, and selectively reduces immunosuppressive Mφ2. Collectively, these findings provide a strong rationale for combining H2O2 with IR to alleviate hypoxia-driven immunosuppression and improve clinical outcomes in solid tumors."

Journal • Oncology • Solid Tumor • IFNG • MRC1

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Kortuc, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer (clinicaltrials.gov) - P2 | N=184 | Recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Trial primary completion date: Apr 2027 ➔ Jun 2028

First-in-human • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Non-surgical breast-conserving treatment using Kochi oxydol-radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer. (PubMed, Oncol Lett) - "These findings suggest that KORTUC-BCT is a minimally invasive and well-tolerated therapy with promising outcomes, particularly for patients with early-stage breast cancer who decline surgery. This clinical study was registered in the UMIN clinical trials registry (UMIN000003734; June 10, 2010)."

Journal • Breast Cancer • Oncology • Solid Tumor

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer (clinicaltrials.gov) - P2 | N=184 | Recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Trial completion date: Nov 2027 ➔ Apr 2028 | Trial primary completion date: Nov 2027 ➔ Apr 2027

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Operable breast cancer patients who refuse surgery can be cured by definitive radiotherapy with or without radiosensitization strategy (ESTRO 2025) - "In 35 patients, intratumoral hydrogen peroxide injection (Kochi Oxydol Radiation Therapy for Unresectable Carcinomas [KORTUC] treatment or hyperthermia with oral tegafur-gimeracil-oteracil potassium (S-1) was also used to sensitize the tumors to radiation... The results obtained so far do not seem to differ from those obtained by surgery. Cosmetic outcomes were satisfactory in most patients. Our method might be a good treatment option for operable breast cancer patients who do not wish to undergo surgery."

Clinical • Surgery • Breast Cancer • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor

Achieving a Good Response in Myxofibrosarcoma With Uncontrollable Bleeding Using an Enzyme-Targeting Radiosensitization Treatment: A Case Report. (PubMed, Cureus) - "A good response was observed. This case report highlights the effectiveness of KORTUC I and II. Reports on KORTUC for sarcomas are limited, underscoring the necessity for future examination of cases not indicated for surgical intervention."

Journal • Oncology • Sarcoma • Solid Tumor

Revisiting hydrogen peroxide as radiosensitizer for solid tumor cells. (PubMed, Radiother Oncol) - "SH in KORTUC mitigates H2O2 cytotoxicity. We demonstrate that KORTUC overcomes hypoxia-induced radioresistance through inhibition of OCR, via complex I- and II-blockade, leading to tumor reoxygenation. Understanding KORTUC's pathways is essential for developing effective cancer combination therapies."

Journal • Tumor cell • Oncology • Solid Tumor

Tumour reoxygenation after intratumoural hydrogen peroxide (KORTUC) injection: a novel approach to enhance radiosensitivity. (PubMed, BJC Rep) - "Intratumoural KORTUC represents a novel oxygen delivery method, which can be exploited to enhance radiation response. If efficacy is confirmed in the ongoing phase 2 breast trial it could improve treatment of several tumour types where hypoxia is known to affect radiotherapy outcomes."

Journal • Breast Cancer • Oncology • Solid Tumor

KORTUC breast-conserving therapy for stage 0-IIA breast cancer (JBCS 2024) - "The median age was 59 years (38-83). The median observation period was 25 months (12-86). The only acute adverse event from KORTUC injection was temporary pain associated with the injection."

Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Oncology • Pain • Solid Tumor

KORTUC breast-conserving therapy for stage IIB-IIIC breast cancer (JBCS 2024) - "The median age was 48 years (range 33-74), the median follow-up period was 33 months (range 9-43), and 5 patients were in stage IIB, IIIA, IIIB, and IIIC. Four patients (21%) received chemotherapy, and 10 patients (52.6%) received hormonal therapy. The 3-year overall survival rate was 100%, and the 3-year disease-free survival rate was 48.2%."

Breast Cancer • Oncology • Solid Tumor

Imaging and transcriptomic biomarkers of breast tumour response to radiotherapy in the KORTUC trial (ESTRO 2024) - P2 | "Preliminary analysis has shown interesting associations between radiation response and angiogenesis and immune/inflammatory pathways. Our findings also suggest that early microvasculature changes seen on SRUS after RT have the potential to predict long-term response. Work is ongoing to investigate this in a larger cohort (as trial S5364 Radiobiology - Tumour biology recruitment proceeds) with the addition of a paired 12-month biopsy for comparison with longitudinal SRUS and DCE/DW-MRI results."

Biomarker • Breast Cancer • Fibrosis • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CA9 • CAT • CD177 • CD31 • ER • HER-2 • PECAM1 • SLC2A1

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Kortuc, Inc. | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Cervical Cancer • Oncology • Solid Tumor

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer (clinicaltrials.gov) - P2 | N=184 | Recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Trial completion date: Dec 2026 ➔ Nov 2027 | Trial primary completion date: Dec 2026 ➔ Nov 2027

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

KORTUC, a novel hydrogen peroxide‑based radiosensitizer for the enhancement of brachytherapy in patients with unresectable recurrent uterine cervical cancer. (PubMed, Oncol Lett) - "Based on this finding, KORTUC with external irradiation is considered to be an optimal treatment strategy for patients with newly diagnosed LRCC this disease. Additionally, KORTUC may be an effective radiation response enhancer in multiple cancer types in which locoregional control after RT alone remains poor."

Journal • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer

Combined treatment with direct hydrogen peroxide administration and irradiation promotes an abscopal effect in mouse models (AACR 2023) - "Indeed, H2O2 has been clinically developed as a radiosensitizer (development code: KRC-01)... Intratumoral H2O2 administration enhanced the abscopal effect through activating antitumor immunity by RT."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CD8

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Kortuc, Inc. | Initiation date: Jan 2023 ➔ Jun 2023

Metastases • Trial initiation date • Cervical Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Kortuc, Inc.

New P1/2 trial • Cervical Cancer • Oncology • Solid Tumor