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Clinical Trials/NCT05570422
NCT05570422RecruitingPhase 1

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

Kortuc, Inc.9 sites in 3 countries70 target enrollmentStarted: March 1, 2026Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
70
Locations
9
Primary Endpoint
AEs of special interest

Study Overview

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.

Detailed 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.

Phase 1 component (n=10) Phase 1 component is a dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT).

KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT.

There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu)

After 5 subjects of Cohort 1 have completed CRT+BT, the safety review committee (SRC) will evaluate the safety and tolerability of KRC-01 once-a-week dosing and determine Go/ No Go decision to Cohort 2 (twice-a-week dosing).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • 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
  • 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.

Arms & Interventions

dose-escalation single arm

Experimental

Dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT).

KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT.

There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu)

Intervention: KRC-01 (Drug)

dose-escalation single arm

Experimental

Dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT).

KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT.

There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu)

Intervention: brachytherapy (Radiation)

dose-escalation single arm

Experimental

Dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT).

KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT.

There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu)

Intervention: External Beam Radiation Therapy (Radiation)

dose-escalation single arm

Experimental

Dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT).

KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT.

There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu)

Intervention: cisplatin (Drug)

Outcomes

Primary Outcomes

AEs of special interest

Time Frame: 36 month

(local pain, radiation dermatitis, tumor lysis syndrome, superficial soft tissue fibrosis, vaginal stenosis, gastrointestinal/urinary AEs, and severe and medically significant bleeding (requires urgent intervention) after intratumoral injection)

Tolerance

Time Frame: week 1 to 6

• Number of patients who have a significant treatment delays/interruption (total duration \> 59 days)

Adverse Events

Time Frame: 36 month

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a study drug that does not necessarily have a causal relationship with the treatment.

Physical examination

Time Frame: at the time of Screening and at Week 6 and partial examination will be done weekly in between to document relevant changes.

The physical examination will include: * General appearance * Head, eyes, ears, nose, and throat * Respiratory * Cardiovascular * Musculoskeletal * Abdomen * Neurologic * Extremities * Dermatologic * Lymphatic Partial examination, patient will verbally report changes since last week.

Secondary Outcomes

  • Progression-free survival(: minimum 2 years, maximum 3 years)
  • Overall survival(minimum 2 years, maximum 3 years)
  • Health-related quality of life (QOL)(minimum 2 years, maximum 3 years)
  • Disease-free survival(minimum 2 years, maximum 3 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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