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RECRUITING
NCT05570422
PHASE1

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

Sponsor: Kortuc, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-03-01

Completion Date

2027-03-30

Last Updated

2026-04-08

Healthy Volunteers

No

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

Locations (4)

Site 2

Chandigarh, India

Site 5

Bangkok, Bangkok, Thailand

Site 4

Chiang Mai, Thailand

Site 3

Manchester, United Kingdom