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

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

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.

Conditions2

Interventions2

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