NCT07069335 A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
| NCT ID | NCT07069335 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-05-15 |
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 24 participants in total. It began in 2025-06-17 with a primary completion date of 2026-05-15.
⚠ 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
This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.
Eligibility Criteria
Inclusion Criteria: 1. Females aged 19 -74 at the time of consent 2. Those who voluntarily signed the informed consent to participate in this study 3. Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening. Exclusion Criteria: 1. Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions 2. Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products 3. Those who are pregnant, suspected of pregnancy, or nursing
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07069335 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 74 Years, studying Ovarian 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 NCT07069335 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 NCT07069335 currently recruiting?
Yes, NCT07069335 is actively recruiting participants. Contact the research team at syoh@boryung.co.kr for enrollment information.
Where is the NCT07069335 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07069335 clinical trial?
NCT07069335 is sponsored by Boryung Pharmaceutical Co., Ltd. The trial plans to enroll 24 participants.
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