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 range18 Years
SexFEMALE
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✕. 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;
✕. 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;
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
✕. 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);