Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies (NCT07311538) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies
56 participantsStarted 2025-12
Plain-language summary
This study is a single-arm, open-label, multicenter Phase IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of BRY812 for Injection in patients with LIV-1-positive advanced gynecological malignancies. The study comprises two cohorts. For Cohort 1 (ovarian cancer), a Simon's two-stage design is adopted. In the first stage, 13 evaluable subjects will be enrolled. If fewer than 3 subjects achieve an objective response among these 13, enrollment in this cohort will be terminated. Otherwise, the cohort will proceed to the second stage, and additional 23 evaluable subjects will be enrolled, bringing the total to 36. If at least 10 out of the 36 evaluable subjects achieve an objective response, the cohort will be considered worthy of further investigation. Cohort 2 (endometrial cancer and ovarian clear cell carcinoma) plans to enroll approximately 20 subjects in a single stage.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. No seizures within \> 12 consecutive weeks with or without the treatment of antiepileptic drugs;
. Glucocorticoids are not required within the 2 weeks prior to the first dose;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy assessment (RECIST v1.1)
Timeframe: Baseline, every 6 weeks after first dose up to 24 weeks, every 12 weeks thereafter, through study completion, an average of 6 months
. Two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;
. The conditions remain stable and asymptomatic for more than 1 month after treatment;
. Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA class III-IV), myocardial infarction, severe arrhythmias (such as sustained ventricular tachycardia and ventricular fibrillation), congenital long QT syndrome, torsade de pointes, and symptomatic pulmonary embolism within 6 months before enrollment;
. Uncontrolled hypertension (at least 2 consecutive measurements of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
. Echocardiogram (ECHO) or multigated acquisition scan (MUGA) shows left ventricular ejection fraction (LVEF) \< 50%;
. During the screening period, the mean corrected (by Fridercia's formula) QT interval on three consecutive electrocardiograms is prolonged (\> 470 ms);