At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- KRC-01 (drug), External Beam Radiation Therapy (radiation), cisplatin (drug), brachytherapy (radiation)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- KRC-01 — drug: KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. · External Beam Radiation Therapy — radiation: * Target definition for EBRT will be based on 3D imaging by computed tomography, positron emission tomography with computed tomography, or MRI. · cisplatin — drug: * Weekly concomitant cisplatin (40 mg/m2) during EBRT * Neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2) are not allowed. · brachytherapy — radiation: * BT treatment planning will be based on 3D-image-guided BT by MRI.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at the safety, tolerability and early effectiveness of a new treatment called KRC-01 in women with cervical cancer that has spread locally (stage II or III) but not to other parts of the body. Participants must not have had chemotherapy or radiotherapy for cervical cancer before. The trial is paid for (sponsored) by Kortuc, Inc.
Who can take part
- You can give written informed agreement (consent) to take part.
- You are a woman aged 18 or older.
- You have been diagnosed with certain common types of cervical cancer (squamous cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma) confirmed by tissue tests.
- Your cancer is stage II or III locally advanced cervical cancer.
- There is no sign the cancer has spread to other parts of the body.
- You have at least one tumour bigger than 5 cm across that has not had radiotherapy before, measured by an MRI (magnetic resonance imaging) scan within 28 days before the trial starts.
- You have not had chemotherapy or radiotherapy for cervical cancer before.
- You plan to have standard treatment with external beam radiotherapy (EBRT) plus 5 cycles of a chemotherapy drug called cisplatin, followed by brachytherapy (internal radiotherapy, BT), all finished within 8 weeks of starting.
- You are expected to live at least 3 months.
- The target tumour can be reached with an injection directly into it.
- You can carry out day-to-day activities with little or no help (performance status 0 or 1 on the ECOG scale).
- If you could become pregnant, you have a negative pregnancy test before starting chemoradiotherapy and agree to avoid pregnancy from consent until 3 months after radiotherapy ends.
Who may not be able to
- You have had another cancer, apart from a common skin cancer called basal cell carcinoma.
- You have a rarer type of cervical cancer, such as small cell (neuroendocrine), melanoma, clear cell, or other rare variants.
- You have had radiotherapy to the pelvis or abdomen before.
- You have had your womb fully or partly removed (total or partial hysterectomy).
- You have had radiotherapy before surgery.
- You are having chemotherapy before surgery or other cancer treatment that is not part of the trial, apart from weekly cisplatin (40 mg/m2).
- The position or size of your disease makes it hard to give safe injections into the tumour.
- You cannot have pelvic radiotherapy, for example because of inflammatory bowel disease or collagen vascular disease.
- You cannot have an MRI scan.
- You take blood-thinning medicines (anticoagulants) or your blood clotting tests are not normal.
- You are pregnant or breastfeeding.
- You have a high medical risk because of another (non-cancer) illness or an active infection that is not controlled.
- You took part in another trial of an experimental drug, device or biological treatment in the past 3 months, apart from an observational study.
What taking part involves
- • Injections of the study treatment (KRC-01) directly into the tumour.
- • External beam radiotherapy (EBRT) with 5 cycles of the chemotherapy drug cisplatin.
- • Brachytherapy (internal radiotherapy, BT) after the external radiotherapy and chemotherapy, with all of this treatment finished within 8 weeks of starting.
- • MRI (magnetic resonance imaging) scans to measure the tumour before treatment starts.
Time commitment: Not stated — ask the trial team. The data says the radiotherapy and chemotherapy part must be completed within 8 weeks of starting, and pregnancy must be avoided until 3 months after radiotherapy ends.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 70
- Started
- 2026-03-01
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for cervical cancer
- • Phase1 - 70 participants
- • This is a seamless Phase 1/2 study consisting of two components
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cervical cancer
- • Female only
Where?
- • Manchester - Site 3
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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. Phase 1 component (n=10) Phase 1 component is a dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT). KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT. There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu) After 5 subjects of Cohort 1 have completed CRT+BT, the safety review committee (SRC) will evaluate the safety and tolerability of KRC-01 once-a-week dosing and determine Go/ No Go decision to Cohort 2 (twice-a-week dosing). After all 10 subjects have completed CRT+BT, the SRC will evaluate the safety and tolerability of KRC 01 and determine Go/ No Go decision to Phase 2 component with optimal dosing regimen. Phase 2 component (n=60) Phase 2 component is a randomized, open label study. All eligible subjects will be randomized to Standard of care (SOC) group or SOC with KRC-01 group. All subjects will receive EBRT with cisplatin (40 mg/m2) IV once-a-week for 5 weeks (sixth dose optional) followed by image-guided BT. Only for KRC-01 group, KRC-01 will be dosed intratumorally at the optimal dosing schedule selected in Phase 1 component within 2 hours prior to EBRT starting from second week of EBRT.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Provide written agreement to take part before participation.
- ✓Female subjects age 18 years or older.
- ✓Histologically diagnosed squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- ✓FIGO stage II and III that has grown locally cervical cancer.
- ✓No evidence of that has spread disease.
Who cannot take part
- ✗Other primary malignancies except basal cell carcinoma of the skin.
- ✗Histologically diagnosed small cell (neuroendocrine), melanoma, clear cell and other rare variants of the classical...
- ✗Previous pelvic or abdominal radiotherapy.
- ✗Previous total or partial hysterectomy.
- ✗Combination of preoperative radiotherapy with surgery.
See the full criteria
Where Is This Study? (1 UK site)
Site 3
Manchester, United Kingdom
How to Get in Touch
Martine Francis
Sponsor contactCONTACT
Minako Koga
Sponsor contactCONTACT