Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
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
NCT05570422CI-TRIAL-00107679recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| KRC-01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose-escalation single arm
- description
- 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)
- interventionNames
- Drug: KRC-01
- Radiation: External Beam Radiation Therapy
- Drug: cisplatin
- Radiation: brachytherapy
Primary outcomes (4)
- measure
- Adverse Events
- timeFrame
- 36 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.