RecruitingPHASE1INTERVENTIONAL

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

This research is investigating a new medication called KRC-01 for women with cervical cancer. The study is split into two parts. The first part (Phase 1) involves a small number of patients to check if KRC-01 is safe and how well people tolerate different doses. The second part (Phase 2) will involve more patients and compare KRC-01 combined with standard treatments (radiotherapy and chemotherapy) to standard treatments alone. Researchers want to find out if adding KRC-01 helps to reduce the size of the cancer. Participants will be aged 18 or over and have certain types of cervical cancer that hasn't spread.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Kortuc, Inc.

Enrolment target

Start

01 Mar 2026

Estimated completion

30 Mar 2027

Cervical Cancer

What is this study about?

This study is about finding new and better ways to treat cervical cancer. Researchers are looking at a new medication, let's call it KRC-01, and how it works alongside the treatments doctors usually give, which include radiotherapy and a chemotherapy drug called cisplatin. The main goal is to see if KRC-01 is safe for patients and if it can help shrink the cancer more effectively.

The study has two main stages. The first stage, Phase 1, is like a careful first look. A small group of about 10 women will receive KRC-01 along with their standard treatments. This helps the doctors understand the best dose to give and check for any side effects. Once they are confident about the safety and dose, the study moves to Phase 2.

In Phase 2, a larger group of about 60 women will take part. They will be split into two groups by chance: one group will receive the standard treatment only, and the other group will receive the standard treatment plus KRC-01. This allows the doctors to compare the two groups and see if KRC-01 makes a difference in shrinking the cancer. This kind of research is really important for developing new options for patients with cervical cancer.

Key takeaways

This study is testing a new drug (KRC-01) for cervical cancer.
It aims to find out if KRC-01 is safe and helps shrink tumours when added to standard treatments.
The study involves women with certain types and stages of cervical cancer.
Participants will receive standard radiotherapy and chemotherapy, plus KRC-01 for some.
The study has two parts: first checking safety, then comparing effectiveness.

Who may be eligible?

This study is specifically for women aged 18 or older who have been diagnosed with certain types of cervical cancer. This includes squamous cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma. Your cancer should be at a stage called FIGO stage II or III, meaning it's locally advanced but hasn't spread to other parts of your body. You also need to have at least one tumour that is larger than 5 cm and hasn't been treated with radiation before.

To be considered, you shouldn't have had any chemotherapy or radiotherapy for cervical cancer in the past. You will also need to be well enough to receive treatment, with a good feeling of overall health and an expectation of living for at least 3 more months. Importantly, the doctors need to be able to safely give the KRC-01 medication directly into your tumour.

There are also some reasons why you might not be able to join. For example, if you have other types of cancer (apart from a common skin cancer), if your cervical cancer is a very rare type, or if you've had certain radiation treatments or surgeries in the pelvic area before. People who are pregnant, breastfeeding, on blood thinners, or have certain other medical conditions might also not be able to participate. Your doctor will carefully review all these points with you.

Quick self-check

Are you a woman aged 18 or older?
Do you have certain types of cervical cancer (squamous cell, adenocarcinoma, or adeno-squamous) that hasn't spread?
Have you *not* had chemotherapy or radiotherapy for cervical cancer before?
Are you able to undergo standard treatments including radiotherapy and chemotherapy?
Is your tumour accessible for safe injections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first be asked to sign a consent form, making sure you understand everything involved. Regardless of which group you are in, all participants will receive standard treatment for cervical cancer. This involves external beam radiotherapy (a type of radiation from outside the body) combined with a chemotherapy drug called cisplatin, given into a vein once a week for about 5 weeks. This is usually followed by internal radiation, called brachytherapy.

If you are in the group receiving KRC-01, this medication will be injected directly into your tumour within a couple of hours before your external beam radiotherapy sessions, starting from the second week of radiotherapy. In Phase 1, this might happen once or twice a week. In Phase 2, the schedule for KRC-01 will be based on what was found to be best in Phase 1. Doctors will regularly check your health, how well you are tolerating the treatments, and if the cancer is responding. The full duration of the study will vary, but regular check-ups will continue after your treatments are completed.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new investigational treatment that might improve the outcome of your cervical cancer. However, it's important to remember that KRC-01 is a new medication, and its long-term effects are not yet fully known. There are risks involved, including potential side effects from KRC-01 itself, in addition to the known side effects of standard radiotherapy and chemotherapy. These could include discomfort or pain from injections, or other reactions. Your doctors will carefully monitor you for any side effects and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

Site 2
Chandigarh, India· Not yet recruiting
Site 5
Bangkok, Thailand· Recruiting
Site 4
Chiang Mai, Thailand· Recruiting
Site 3
Manchester, United Kingdom· Not yet recruiting

Common questions

What is KRC-01?

KRC-01 is a new medication being tested in combination with standard treatments for cervical cancer to see if it helps shrink tumours.

What stage of cancer is this study for?

This study is for women with locally advanced cervical cancer, specifically FIGO stage II or III, that hasn't spread to distant parts of the body.

Will I definitely get the new medication?

In Phase 1, all participants get KRC-01. In Phase 2, you have a 50/50 chance of being in the KRC-01 group or the standard treatment-only group.

How is KRC-01 given?

KRC-01 is given by injection directly into the tumour, usually before your radiotherapy treatment sessions.

What are the common treatments for cervical cancer?

Common treatments usually involve external radiotherapy, chemotherapy (like cisplatin), and internal radiotherapy (brachytherapy).

How to find out more

Martine Francis

martine@mafinc.com 13013438894 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.