Tests KRC-01 injected into tumors with radiotherapy for locally advanced cervical cancer
Tests KRC-01 injected into the tumor with radiotherapy in adults with cervical cancer.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
Key facts
- Where
- Bangkok and Chiang Mai, ThailandSee the 2 sites
- Phase
- Phase 1
Where in Thailand
- BangkokBangkok, ThailandTaking people
- Chiang MaiChiang Mai, ThailandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kortuc, Inc.
- Trial code
- NCT05570422
- Record updated
- 8 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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); Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months, except an observational study; Other primary malignancies except basal cell carcinoma of the skin; 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; High medical risks because of non-malignant systemic disease or with active uncontrolled infection; Histologically diagnosed small cell (neuroendocrine), melanoma, clear cell and other rare variants of the classical adenocarcinoma at cervices; Contraindications to MRI; Patients on anticoagulants or deranged coagulation profile; Pregnancy or nursing.