MedTrace Logo

Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies

NCT07311538 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-31

No results posted yet for this study

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

Interventions

DRUG

BRY812 for injection

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.

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-31
Completion
2028-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311538 on ClinicalTrials.gov