NCT07371104 Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
| NCT ID | NCT07371104 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-04-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: 1\. Female subjects aged 19 years or older at the time of obtaining written informed consent. 2\. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria: 1. Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 consecutive days. 2. Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening. Exclusion Criteria: 1. Subjects with a history of hypersensitivity to the investigational product or any of its components. 2. Subjects with any of the following concomitant conditions: (1) Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis. 3\. Subjects who have received the following drug and non-drug treatments at screening: 1. Radiotherapy within 4 weeks prior to screening. 2. Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery. 5\. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.
Frequently Asked Questions
Who can join the NCT07371104 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07371104 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07371104 currently recruiting?
Yes, NCT07371104 is actively recruiting participants. Visit ClinicalTrials.gov or contact Daewoong Pharmaceutical Co. LTD. to inquire about joining.
Where is the NCT07371104 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07371104 clinical trial?
NCT07371104 is sponsored by Daewoong Pharmaceutical Co. LTD.. The trial plans to enroll 40 participants.
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