A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01

NCT05570422 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KRC-01-C01
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 4

Brief 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. 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  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)

  week 1 to 6

Secondary Outcomes (4)

• Progression-free survival

  : minimum 2 years, maximum 3 years

• Overall survival

  minimum 2 years, maximum 3 years

• Disease-free survival

  minimum 2 years, maximum 3 years

• Health-related quality of life (QOL)

  minimum 2 years, maximum 3 years

Other Outcomes (2)

• CRT poor responder rate

  Out to Week 4 or 5

• Feasibility of hypoxia imaging

  Screening and after the completion of KRC-01 dosing (between Week 6 to Month 3).

Study Arms (1)

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)

Drug: KRC-01; Radiation: External Beam Radiation Therapy; Drug: cisplatin; Radiation: brachytherapy

Interventions

KRC-01 DRUG

KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer.

dose-escalation single arm

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. * Intensity-modulated radiotherapy (IMRT) must be used. * IMRT should be given once daily Monday-Friday, 5 fractions per week.

dose-escalation single arm

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. * Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed.

Also known as: Chemotherapy

dose-escalation single arm

brachytherapy RADIATION

* BT treatment planning will be based on 3D-image-guided BT by MRI. * Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT

dose-escalation single arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: females at birth currently with a cervix
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Kortuc, Inc.: lead

Study Sites (4)

Site 2

Chandigarh, India

NOT YET RECRUITING

Site 5

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Site 4

Chiang Mai, Thailand

RECRUITING

Site 3

Manchester, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Drug Therapy; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Radiotherapy

Central Study Contacts

Martine Francis

CONTACT

13013438894; martine@mafinc.com

Minako Koga

CONTACT

2026156004; mkoga@kmphc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 open label

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: October 6, 2022
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

GB (1); TH (2); IN (1)