Actively Recruiting
A Phase IIa Study to Evaluate NBQ72S
Led by Nantong Bencao Quadriga Medical Technology Co. Ltd. · Updated on 2026-04-13
10
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase IIa, single-arm, open-label study was conducted to evaluate the efficacy and safety of NBQ72S, in patients with leptomeningeal metastases from breast cancer. All patients will receive the study drug every 28 days until withdrawal from treatment.
CONDITIONS
Official Title
A Phase IIa Study to Evaluate NBQ72S
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with biopsy-confirmed breast cancer and leptomeningeal metastasis, with or without brain metastases
- Karnofsky Performance Status (KPS) of 60 or higher
- Adequate bone marrow function: neutrophil count ≥1,500/mm³, platelet count ≥100,000/mm³, hemoglobin ≥9 g/dL
- Adequate kidney function: serum creatinine ≤1.5 times upper normal limit or creatinine clearance ≥50 mL/min
- Adequate liver function: total bilirubin ≤1.5 times upper normal limit (or <3 times if liver involved or history of Gilbert's syndrome), AST and ALT ≤2.5 times upper normal limit (or ≤5 times if liver involved)
- Use of effective contraception during the study and for 7 months after last dose for females of childbearing potential
You will not qualify if you...
- Presence of any other active cancers except treated basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma
- Intolerance or severe allergic reaction to substances in the study drug, including sulfobutylether-β-cyclodextrin, mefenamic acid, bendamustine, chloramphenicol, or nitrogen mustard chemotherapy agents
- Receipt of live vaccine or experimental drug within 30 days before starting treatment
- Pregnancy or breastfeeding
- Any other condition that could affect eligibility as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
R
Raylene Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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