Ovarian CancerPhase 1NCT07532148
Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study testing CKD-215 and D215 in people with Ovarian Cancer, run by Chong Kun Dang Pharmaceutical.
Trial summary
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215 Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- CKD-215 and D215
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- 18.0kg/m2≤body mass index(BMI)≤28.0kg/m2
Who cannot join
- Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- Patients with central nervous system metastases, unless clinically stable after treatment
- CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
- Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215
Read the detailed description
A Multi-center, Randomized, Open-Label, Multiple-dose, Two-Stage, Two-treatment, Two-period, Crossover Study
- Conditions
- Ovarian Cancer
- Being tested
- CKD-215, D215
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-215Drug
Also called TEST drug
2 tablets BID at 12-hour intervals for 7 days
D215Drug
Also called Reference drug
2 tablets BID at 12-hour intervals for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Period 1: Test drug(CKD-215) Period 2: Reference drug(D215) Receives: Drug: CKD-215; Drug: D215 |
| Experimental group 2 | Experimental | Period 1: Reference drug(D215) Period 2: Test drug(CKD-215) Receives: Drug: CKD-215; Drug: D215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Area under the plasma concentration-time curve over the dosing interval at steady state
Measured: 0~12 hours
Css,max
Maximum observed plasma concentration at steady state
Measured: 0~12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeong-Yeol Park, Ph.D, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532148
- Sponsor's protocol ID
- A163_01BE2510
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT07532148
- Acronym / sponsor ID
- A163_01BE2510
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215
Detailed description
A Multi-center, Randomized, Open-Label, Multiple-dose, Two-Stage, Two-treatment, Two-period, Crossover Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: CKD-215, Drug: D215Period 1: Test drug(CKD-215) Period 2: Reference drug(D215) |
| Experimental group 2 | Experimental | Drug: CKD-215, Drug: D215Period 1: Reference drug(D215) Period 2: Test drug(CKD-215) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- 18.0kg/m2≤body mass index(BMI)≤28.0kg/m2
Key exclusion criteria (4 listed)
- Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- Patients with central nervous system metastases, unless clinically stable after treatment
- CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
- Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-215Also: TEST drug2 tablets BID at 12-hour intervals for 7 days | Drug | Experimental group 1, Experimental group 2 |
| D215Also: Reference drug2 tablets BID at 12-hour intervals for 7 days | Drug | Experimental group 1, Experimental group 2 |
Primary outcome
AUCtau
Time frame: 0~12 hours
Area under the plasma concentration-time curve over the dosing interval at steady state
Css,max
Time frame: 0~12 hours
Maximum observed plasma concentration at steady state
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong-Yeol Park, Ph.D study chair
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-215 and D215 in people with Ovarian Cancer, run by Chong Kun Dang Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Yeol Park, Ph.D (82-2-3010-3646, catgut1-0@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau (time frame: 0~12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.