Trial Title:
A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01
NCT ID:
NCT05570422
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Phase 1 open label
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KRC-01
Description:
KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%.
Hydrogen peroxide is the active ingredient for this radiosensitizer.
Arm group label:
dose-escalation single arm
Intervention type:
Radiation
Intervention name:
External Beam Radiation Therapy
Description:
- Target definition for EBRT will be based on 3D imaging by computed tomography,
positron emission tomography with computed tomography, or MRI.
- Intensity-modulated radiotherapy (IMRT) must be used.
- IMRT should be given once daily Monday-Friday, 5 fractions per week.
Arm group label:
dose-escalation single arm
Intervention type:
Drug
Intervention name:
cisplatin
Description:
- Weekly concomitant cisplatin (40 mg/m2) during EBRT
- Neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from
weekly concomitant cisplatin (40 mg/m2) are not allowed.
- Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed.
Arm group label:
dose-escalation single arm
Other name:
Chemotherapy
Intervention type:
Radiation
Intervention name:
brachytherapy
Description:
- BT treatment planning will be based on 3D-image-guided BT by MRI.
- Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT
Arm group label:
dose-escalation single arm
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).
After all 10 subjects have completed CRT+BT, the SRC will evaluate the safety and
tolerability of KRC 01 and determine Go/ No Go decision to Phase 2 component with optimal
dosing regimen.
Phase 2 component (n=60) Phase 2 component is a randomized, open label study. All
eligible subjects will be randomized to Standard of care (SOC) group or SOC with KRC-01
group.
All subjects will receive EBRT with cisplatin (40 mg/m2) IV once-a-week for 5 weeks
(sixth dose optional) followed by image-guided BT. Only for KRC-01 group, KRC-01 will be
dosed intratumorally at the optimal dosing schedule selected in Phase 1 component within
2 hours prior to EBRT starting from second week of EBRT.
Criteria for eligibility:
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.
Gender:
Female
Gender based:
Yes
Gender description:
females at birth currently with a cervix
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 2
Address:
City:
Chandigarh
Country:
India
Contact:
Last name:
Martine Francis
Phone:
13013438894
Email:
martine@mafinc.com
Facility:
Name:
Site 1
Address:
City:
Visakhapatnam
Country:
India
Contact:
Last name:
Martine Francis
Phone:
3013438894
Email:
martine@mafinc.com
Facility:
Name:
Site 5
Address:
City:
Bangkok
Country:
Thailand
Contact:
Last name:
Martine Francis
Phone:
13013438894
Email:
martine@mafinc.com
Contact backup:
Last name:
Minako Koga
Phone:
2026156004
Email:
mkoga@kmpc.com
Facility:
Name:
Site 4
Address:
City:
Chiang Mai
Country:
Thailand
Contact:
Last name:
Martine Francis
Phone:
13013438894
Email:
martine@mafinc.com
Contact backup:
Last name:
Minako Koga
Phone:
202-615-6004
Email:
mkoga@kmpc.com
Facility:
Name:
Site 3
Address:
City:
Manchester
Country:
United Kingdom
Contact:
Last name:
Martine Francis
Phone:
13013438894
Email:
martine@mafinc.com
Contact backup:
Last name:
Minako Koga
Phone:
202-615-6004
Email:
mkoga@kmpc.com
Start date:
April 1, 2025
Completion date:
March 30, 2027
Lead sponsor:
Agency:
Kortuc, Inc.
Agency class:
Industry
Source:
Kortuc, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570422
