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

• Status: Not yet recruiting
• Trial end date: 2027-03-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kortuc, Inc.
• Treatments: Cisplatin

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.