ClinicaliQ Trial Snapshot
- A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 — Recruiting • Phase I • Oncology • NCT05570422.
- 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,….
- Sponsor: Kortuc, Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.