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

NCT05570422 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-08

No results posted yet for this study

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

Interventions

DRUG

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.

RADIATION

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.

DRUG

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.

RADIATION

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

Sponsors & Collaborators

  • Kortuc, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-01-30
Completion
2027-03-30
FDA Drug
Yes

Countries

  • India
  • Thailand
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570422 on ClinicalTrials.gov