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

Sponsor
Kortuc, Inc.
Study ID
NCT05570422
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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

Study Details

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.

Key Dates

First listed
Oct 6, 2022
Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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)

Primary Outcome Measure

Adverse Events [ Time Frame: 36 month ]

Central Contacts

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