Cervical CancerPhase 1NCT05570422
A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
A Phase 1 study testing KRC-01, External Beam Radiation Therapy and cisplatin in people with Cervical Cancer, run by Kortuc, Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- KRC-01, External Beam Radiation Therapy and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Mar 2026to 30 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent 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 locally advanced cervical cancer.
- No evidence of metastatic disease.
- At least one tumor that qualifies as a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 tumor with tumor size >5 cm diameter, not previously irradiated, at baseline assessed [by magnetic resonance imaging (MRI)] within 28 days before Day 1.
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- No prior chemotherapy or radiotherapy for cervical cancer.
- Intention to undergo treatment including EBRT with 5 cycles of cisplatin followed by BT; to be completed within 8 weeks of its initiation.
- Patients with predicted life expectancy of 3 months or more.
- Target tumor is accessible for intratumoral injection.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- Negative pregnancy test before start of CRT in women of childbearing potential and an ability/willingness to protect against pregnancy from consent and for 3 months post-RT.
Who cannot join
- 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 adenocarcinoma at cervices.
- Previous pelvic or abdominal radiotherapy.
- Previous total or partial hysterectomy.
- Combination of preoperative radiotherapy with surgery.
- Patients receiving neo-adjuvant chemotherapy or non-protocol antineoplastic treatment apart from weekly cisplatin (40 mg/m2).
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- Anatomical location and/or extent of disease difficult to access for safe intratumoral drug injections.
- Contraindications to the pelvic radiation such as inflammatory bowel disease and collagen vascular disease.
- Contraindications to MRI.
- Patients on anticoagulants or deranged coagulation profile.
- Pregnancy or nursing.
- High medical risks because of non-malignant systemic disease or with active uncontrolled infection.
- Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months, except an observational study.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Thailand2 sites, 2 recruiting
- Recruiting
Site 5
Bangkok, Bangkok, 10700
Wiwatchai Sittiwong, 66 024198674, wiwatchai.sit@gmail.com
Minako Koga, 2026156004, mkoga@kmpc.com
- Recruiting
Site 4
Chiang Mai
Martine Francis, 13013438894, martine@mafinc.com
Minako Koga, 202-615-6004, mkoga@kmpc.com
India1 site, 1 recruiting
- Not yet recruiting
Site 2
Chandigarh
Martine Francis, 13013438894, martine@mafinc.com
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Site 3
Manchester
Martine Francis, 13013438894, martine@mafinc.com
Minako Koga, 202-615-6004, mkoga@kmpc.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cervical Cancer
- Being tested
- KRC-01, External Beam Radiation Therapy, cisplatin, brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRC-01Drug
KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer.
External Beam Radiation TherapyRadiation
- Target definition for EBRT will be based on 3D imaging by computed tomography, positron emission tomography with computed tomography, or MRI.
- Intensity-modulated radiotherapy (IMRT) must be used.
- IMRT should be given once daily Monday-Friday, 5 fractions per week.
cisplatinDrug
Also called Chemotherapy
- 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.
- Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed.
brachytherapyRadiation
- BT treatment planning will be based on 3D-image-guided BT by MRI.
- Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation single arm | Experimental | 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) Receives: Drug: KRC-01; Radiation: External Beam Radiation Therapy; Drug: cisplatin; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a study drug that does not necessarily have a causal relationship with the treatment.
Measured: 36 month
AEs of special interest
(local pain, radiation dermatitis, tumor lysis syndrome, superficial soft tissue fibrosis, vaginal stenosis, gastrointestinal/urinary AEs, and severe and medically significant bleeding (requires urgent intervention) after intratumoral injection)
Measured: 36 month
Physical examination
The physical examination will include:
- General appearance
- Head, eyes, ears, nose, and throat
- Respiratory
- Cardiovascular
- Musculoskeletal
- Abdomen
- Neurologic
- Extremities
- Dermatologic
- Lymphatic Partial examination, patient will verbally report changes since last week.
Measured: at the time of Screening and at Week 6 and partial examination will be done weekly in between to document relevant changes.
Tolerance
- Number of patients who have a significant treatment delays/interruption (total duration > 59 days)
Measured: week 1 to 6
Secondary outcomes (4)
Progression-free survival
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
Measured: : minimum 2 years, maximum 3 years
Overall survival
mortality rates
Measured: minimum 2 years, maximum 3 years
Disease-free survival
Disease progression can be considered as a worsening of a patient's condition attributable to the disease for which the investigational product is being studied. It may be an increase in the severity of the disease under study and/or increases in the symptoms of the disease. An event can be attributed to disease progression even without radiological or biomarker evidence of disease progression.
Deterioration of the disease under study and associated symptoms or findings, including the development of new, or the progression of existing, metastases, should not be regarded as an AE, unless the study medication is considered to have contributed to the progression.
Measured: minimum 2 years, maximum 3 years
Health-related quality of life (QOL)
European Organisation for Research and Treatment of Cancer (EORTC) QOL 30-Item Questionnaire (QLQ-C30) and EORTC 24-Item Cervical Cancer Questionnaire (QLQ-CX24)
Measured: minimum 2 years, maximum 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Mar 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1 open label
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kortuc, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570422
- Sponsor's protocol ID
- KRC-01-C01
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05570422
- Acronym / sponsor ID
- KRC-01-C01
- Conditions
- Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kortuc, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 open label
| Arm | Type | Receives |
|---|---|---|
| dose-escalation single arm | Experimental | Drug: KRC-01, Radiation: External Beam Radiation Therapy, Drug: cisplatin, Radiation: brachytherapyDose-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide written informed consent 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 locally advanced cervical cancer.
- No evidence of metastatic disease.
Key exclusion criteria (13 listed)
- 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 adenocarcinoma at cervices.
- Previous pelvic or abdominal radiotherapy.
- Previous total or partial hysterectomy.
- Combination of preoperative radiotherapy with surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRC-01KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer. | Drug | dose-escalation single arm |
| External Beam Radiation Therapy* Target definition for EBRT will be based on 3D imaging by computed tomography, positron emission tomography with computed tomography, or MRI. * Intensity-modulated radiotherapy (IMRT) must be used. * IMRT should be given once daily Monday-Friday, 5 fractions per week. | Radiation | dose-escalation single arm |
| cisplatinAlso: Chemotherapy* 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. * Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed. | Drug | dose-escalation single arm |
| brachytherapy* BT treatment planning will be based on 3D-image-guided BT by MRI. * Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT | Radiation | dose-escalation single arm |
Primary outcome
Adverse Events
Time frame: 36 month
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a study drug that does not necessarily have a causal relationship with the treatment.
AEs of special interest
Time frame: 36 month
(local pain, radiation dermatitis, tumor lysis syndrome, superficial soft tissue fibrosis, vaginal stenosis, gastrointestinal/urinary AEs, and severe and medically significant bleeding (requires urgent intervention) after intratumoral injection)
Physical examination
Time frame: at the time of Screening and at Week 6 and partial examination will be done weekly in between to document relevant changes.
The physical examination will include: * General appearance * Head, eyes, ears, nose, and throat * Respiratory * Cardiovascular * Musculoskeletal * Abdomen * Neurologic * Extremities * Dermatologic * Lymphatic Partial examination, patient will verbally report changes since last week.
Tolerance
Time frame: week 1 to 6
• Number of patients who have a significant treatment delays/interruption (total duration > 59 days)
4 secondary outcomes
Progression-free survival
Time frame: : minimum 2 years, maximum 3 years
Overall survival
Time frame: minimum 2 years, maximum 3 years
Disease-free survival
Time frame: minimum 2 years, maximum 3 years
Health-related quality of life (QOL)
Time frame: minimum 2 years, maximum 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KRC-01, External Beam Radiation Therapy and cisplatin in people with Cervical Cancer, run by Kortuc, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, India, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine Francis (13013438894, martine@mafinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 36 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.