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New treatment option for Breast Cancer
Official title A Phase IIa Study to Evaluate NBQ72S
ClinicalTrials.gov ID: NCT06810804
What this study is testing
What is NBQ72S?
NBQ72S is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as QBS10072S.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The patient must have histological evidence confirming the diagnosis of breast cancer with leptomeningeal metastasis: a. Breast cancer must be...
- The patient's Karnofsky Performance Status (KPS) must be ≥60.
- The patient must have adequate bone marrow function, including:
- Absolute neutrophil count (ANC) ≥1,500/mm³ or ≥1.5 x 10⁹/L;
- Platelet count ≥100,000/mm³ or ≥100 x 10⁹/L;
You likely can't join if
- Patients with any other active malignancies unrelated to the primary tumor, except for those with basal cell carcinoma, squamous cell carcinoma, or...
- Patients who are intolerant to any substance in the investigational product, including sulfobutylether-β-cyclodextrin, mefenamic acid, bendamustine...
- Patients who have received a live vaccine or experimental drug within 30 days prior to Cycle 1, Day 1 (C1D1).
- Pregnant or breastfeeding patients.
- Any other conditions that may affect the patient's eligibility for this study in the judgment of the investigator
See the full eligibility criteria
- The patient must have histological evidence confirming the diagnosis of breast cancer with leptomeningeal metastasis: a. Breast cancer must be diagnosed through biopsy from either the primary or metastatic sites; b...
- The patient's Karnofsky Performance Status (KPS) must be ≥60.
- The patient must have adequate bone marrow function, including:
- Absolute neutrophil count (ANC) ≥1,500/mm³ or ≥1.5 x 10⁹/L;
- Platelet count ≥100,000/mm³ or ≥100 x 10⁹/L;
- Hemoglobin ≥9 g/dL;
- The patient must have adequate renal function, including: a. Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥50 mL/min. Note: In equivocal cases, a 24-hour urine collection test...
- The patient must have adequate hepatic function, including:
- Total serum bilirubin ≤1.5 x ULN; if the tumor involves the liver, or if the patient has a history of Gilbert's syndrome, total bilirubin must be \<3 x ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; if the tumor involves the liver, these values must be ≤5.0 x ULN;
- Females of childbearing potential and males with fertile partners must agree to use effective contraception during the study and for 7 months following the last dose of study treatment;
- Patients with any other active malignancies unrelated to the primary tumor, except for those with basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma that have been adequately treated.
- Patients who are intolerant to any substance in the investigational product, including sulfobutylether-β-cyclodextrin, mefenamic acid, bendamustine, chloramphenicol, or any nitrogen mustard chemotherapy agents, or who...
- Patients who have received a live vaccine or experimental drug within 30 days prior to Cycle 1, Day 1 (C1D1).
- Pregnant or breastfeeding patients.
- Any other conditions that may affect the patient's eligibility for this study in the judgment of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.