NCT05570422 A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
| NCT ID | NCT05570422 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kortuc, Inc. |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2026-03-01 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05570422 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05570422 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05570422 currently recruiting?
Yes, NCT05570422 is actively recruiting participants. Contact the research team at martine@mafinc.com for enrollment information.
Where is the NCT05570422 trial being conducted?
This trial is being conducted at Chandigarh, India, Bangkok, Thailand, Chiang Mai, Thailand, Manchester, United Kingdom.
Who is sponsoring the NCT05570422 clinical trial?
NCT05570422 is sponsored by Kortuc, Inc.. The trial plans to enroll 70 participants.
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