Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies

NCT07311538 | Not Yet Recruiting Phase 2

• 1 other identifier: BRY812-201
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Gynecological Malignancies

Outcome Measures

Primary Outcomes (1)

• Efficacy assessment (RECIST v1.1)

  The Objective Response Rate (ORR) and other efficacy outcomes will be evaluated by an Independent Review Committee (IRC) using RECIST 1.1 criteria

  Baseline, every 6 weeks after first dose up to 24 weeks, every 12 weeks thereafter, through study completion, an average of 6 months

Secondary Outcomes (3)

• Safety assessment (NCI CTCAE v5.0)

  Immediately after the intervention, through study completion, an average of 6 months

• Pharmacokinetic assessment

  Immediately after the intervention, through study completion, an average of 6 months

• Immunogenicity assessment

  Immediately after the intervention, through study completion, an average of 6 months

Study Arms (1)

BRY812

EXPERIMENTAL

Drug: BRY812 for injection

Interventions

BRY812 for injection DRUG

BRY812 for injection will be administered by intravenous drip, tentatively once per cycle spanning 3 weeks on D1 of each cycle until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation or withdrawal from the study. The dose of each administration will be calculated based on the weight measured prior to such administration. The dosing regimen (dosing frequency and interval) for subsequent study may be adjusted based on prior data. The intravenous drip should last for ≥ 90 min for the first dose and may be adjusted to ≥ 30 min for subsequent doses if the first dose is tolerable.

BRY812

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;
• (2) Female patients, ≥ 18 years of age (based on the date of signing the informed consent form);
• (3) LIV-1 positive, as assessed by a central laboratory
• (4) Patients with histologically or cytologically confirmed locally advanced or metastatic gynecological malignancies are enrolled into two cohorts:
• Cohort 1 (Ovarian Cancer):
• Diagnosis of high-grade serous epithelial ovarian cancer (EOC). Must have received 1 to 3 prior lines of systemic anticancer therapy.
• Cohort 2 (Endometrial Cancer and Ovarian Clear Cell Carcinoma):
• For Endometrial Cancer: Diagnosis of recurrent or metastatic advanced endometrial carcinoma (all histologies except sarcoma). Patients must have received up to 3 prior lines of systemic therapy, platinum-based chemotherapy and anti-PD-1/PD-L1 therapy .
• For Ovarian Clear Cell Carcinoma: Pathologically confirmed ovarian clear cell carcinoma. The definitions for prior therapy lines (1-3 lines) are the same as for Cohort 1.
• (5) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;
• (6) Radiographic disease progression must have occurred during or after the most recent anti-tumor therapy.
• (7) Eastern Cooperative Oncology Group (ECOG) Status 0 to 1;
• (8) Adequate organ and bone marrow function (no treatment with cells, growth factors, or transfusions within 14 days prior to the first administration), as defined below:
• Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L;
• Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;

You may not qualify if:

• (1) Subjects who have previous severe hypersensitivity to BRY812 or known hypersensitivity to any component or excipient of the study drug;
• (2) Subjects who have previously received drugs which target LIV-1, or MMAE-containing drugs, including but not limited to antibody-drug conjugates (ADCs) that utilize MMAE as the cytotoxic payload;
• (3) Subjects who have any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug;
• (4) Subjects who have previous or current presence of two or more primary tumors (excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, and other tumors that have been stable for more than 5 years after treatment);
• (5) Subjects who have symptoms of active central nervous system metastases, except those with brain parenchymal metastases assessed as stable by the investigator based on the following conditions:
• 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;
• (6) Subjects with serious cardiovascular and cerebrovascular diseases and lung diseases, including but not limited to:
• 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);
• Subjects who have interstitial lung diseases, severe impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, and other lung diseases assessed by the investigator as clinically significant;

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Xiaohua Wu, PhD

CONTACT

(+86)18121299168; wu.xh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share