A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
NCT ID: NCT05570422
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2025-12-01
2027-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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dose-escalation single arm
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)
KRC-01
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 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.
cisplatin
* 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.
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
Interventions
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KRC-01
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 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.
cisplatin
* 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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
* 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.
18 Years
FEMALE
No
Sponsors
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Kortuc, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 2
Chandigarh, , India
Site 1
Visakhapatnam, , India
Site 5
Bangkok, , Thailand
Site 4
Chiang Mai, , Thailand
Site 3
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KRC-01-C01
Identifier Type: -
Identifier Source: org_study_id
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