Trial Title:
A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT ID:
NCT06087289
Condition:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carboplatin
Conditions: Keywords:
Fractalkine
Ovarian cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KAND567
Description:
KAND567 is a drug in capsule and is intended to be orally administered approximately
every 12 hours (±1 hour) with an initial loading dose on Day 2 of two times the dose
specified for that dose group (e.g., 2 x 250, 2 x 375, 2 x 500, or 2 x 625 mg KAND567,
depending on the dose group; in Part 2, this is the RPIID), followed by a KAND567 dose
(Day 2, evening dose) that corresponds to the given dose level. On Days 3 to 7, the
subjects will be orally administered the specified KAND567 dose (e.g., 250, 375, 500, or
625 mg BID, depending on the dose group; in Part 2, this is the RPIID).
During the second week of dosing (Days 8 to 14) in Part 1 and Part 2, the subjects will
be orally administered KAND567 at a dose of 250 mg BID. One treatment cycle is defined as
a 21-day period, and each subject will receive up to 6 treatment cycles (or until
unacceptable toxicity or disease progression).
Arm group label:
Part 1: Dose escalation to determine Recommended Phase II Dose (RPIID)
Arm group label:
Part 2: Expansion cohort to evaluate RPIID
Other name:
Fractalkine
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin will be administered i.v. according to standard of care at a dose of AUC 5.
One cycle is defined as a 21-day period with chemotherapy given on Day 1. Each subject
will receive up to 6 treatment cycles (or until unacceptable toxicity or disease
progression). The carboplatin dose should be calculated using the Calvert formula:
Carboplatin dose (mg) = target AUC 5 × (GFR + 25). GFR should be calculated using the
Cockcroft-Gault formula. The maximum carboplatin dose is based on a calculated GFR that
is capped at 125 mL/min for subjects with normal renal function.
Arm group label:
Part 1: Dose escalation to determine Recommended Phase II Dose (RPIID)
Arm group label:
Part 2: Expansion cohort to evaluate RPIID
Summary:
The study is a multicenter, Phase Ib/IIa, open-label, dose-escalation study to evaluate
the safety and tolerability of orally administered KAND567 in combination with
carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in
combination with carboplatin in subjects with recurrent platinum-resistant epithelial
ovarian, fallopian tube, or primary peritoneal cancer.
In Part 1, dose escalation will be based on the recommendation of the Safety Review
Committee (SRC) after review of the emerging safety and tolerability information. Once
the RPIID has been identified in Part 1, the SRC may recommend to the Sponsor to start
Part 2.
An expansion cohort will be enrolled in Part 2 of the study to further evaluate the RPIID
(approximately 20 subjects; may range from 6 to 24 subjects, depending on Part 1). If the
number of subjects with confirmed CX3CR1 expression in tumor cells is below 50%, an
additional 15 subjects may be included in Part 2 of the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically verified high-grade serous or high-grade endometrioid epithelial
ovarian cancer, fallopian tube, or primary peritoneal cancer
- Participants must have recurrent disease, defined as: 1st relapse 3 to 6 months
after completion of the last dose of primary platinum containing treatment, or 2nd
or 3rd relapse within 6 months after completion of the last dose of the latest
platinum-containing regimen (platinum-free interval within 6 months)
- Participants must have had platinum-based chemotherapy in the first-line setting
(primary treatment)
- For BRCA status, samples must be available for analysis; for HRD status, samples
should be available for analysis, if possible. If not already analyzed, the subject
agrees to undergo analysis of HRD and BRCA status on primary tumor tissue and/or
recurrent tumor tissue
- ECOG performance status 0-2
- Subjects must have at least 1 measurable disease according to RECIST 1.1 guidelines
- Able to take oral medications
- Adequate organ function: Absolute neutrophil count ≥ 1.5 x 10^9/L, Platelets > 100 x
10^9/L, Hemoglobin ≥ 80 g/dl, Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula,
Total bilirubin ≤ 1.5 x ULN, Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) ≤ 2.5 x ULN, and Serum albumin ≥ 30 g/L.
- Consent to biopsy taken prior to starting treatment and Week 8 (± 1 week) of
treatment
- At least 18 years of age
- Life expectancy of at least 12 weeks
- Women of childbearing potential must use adequate birth control
- Willingness and ability to comply with study procedures, visit schedules, study
restrictions and requirements
- Able to fully understand and participate in study-related procedures, including
compliance and patient reported outcome
- Written informed consent. Subjects must give informed consent prior to any
study-specific procedure
Exclusion Criteria:
- Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation,
non-epithelial cancers, and cancer types not mentioned in the inclusion criteria
- Primary platinum-refractory disease, defined as tumor progression during or within
12 weeks from end of first platinum treatment
- Concurrent cancer therapy
- Received other than platinum-containing therapy for primary disease (first-line
treatment)
- Received non-platinum-containing chemotherapy in recurrent setting
- Treatment with an investigational agent concurrently, or within the past 3 months
- Previous malignant disease: subjects are not eligible for the study if actively
being treated for invasive cancer other than ovarian cancer
- Immunodeficiency or organ transplant. Autoimmune or inflammatory condition that
requires immunosuppressive or steroid therapy during the course of the study
- Live vaccines within 28 days prior to the first IMP dose
- Major surgery within 28 days prior to the first IMP dose, or not recovered from
previous surgery to CTCAE (v5) grade 1 equivalent
- Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV)
- Transient ischemic attack (TIA) or stroke, including bleeding, within the past 6
months
- Brain and/or liver metastases
- Major cardiac dysfunction defined as > NYHA II
- Gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug
- Serious, uncontrolled, and active infection at enrollment, as determined by the
Investigator
- Pregnancy or breastfeeding
- Persistence of clinically relevant therapy-related toxicity from previous
chemotherapy (any grade 3-4 toxicity or grade ≥ 2 neuropathy)
- Current use of drugs sensitive to CYP3A4 inhibition which cannot be paused or
switched to an alternative within the same class of medication for the period of IMP
administration
- Continuous use of herbal preparations (e.g., St. John's wort) within 2 weeks prior
to enrollment
- Any condition for which, in the opinion of the Investigator, participation would not
be in the best interest of the participant (e.g., compromise well-being) or that
could prevent, limit, or confound the protocol-specified assessments
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Trine Lembrect Jørgensen, MD/PhD
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
0424
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Kristina Lindemann, MD/PhD
Facility:
Name:
Skåne University Hospital
Address:
City:
Lund
Zip:
221 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Susanne Malander, MD/PhD
Facility:
Name:
Karolinska University Hospital
Address:
City:
Solna
Zip:
171 76
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Hanna Dahlstrand, MD/PhD
Start date:
April 20, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Kancera AB
Agency class:
Industry
Collaborator:
Agency:
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Agency class:
Other
Source:
Kancera AB
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087289
