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Breast CancerPhase 2NCT06810804

A Phase IIa Study to Evaluate NBQ72S

A Phase 2 study testing NBQ72S in people with Breast Cancer, run by Nantong Bencao Quadriga Medical Technology Co. Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
NBQ72S
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
22 Apr 2025to 28 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. Leptomeningeal metastasis (with or without brain parenchymal metastases) must be confirmed by imaging examinations(MRI), or by positive or suspicious cerebrospinal fluid cytology; c. There is no restriction on the duration of prior systemic therapy for the primary tumor.
  • 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;
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  • The patient must have adequate renal function, including:
  • 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 can be used to estimate the creatinine clearance more accurately;
  • 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;

Who cannot join

  • 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 have experienced a severe (Grade ≥3) allergic or hypersensitivity reaction to these substances.
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Raylene Liu contact

021-50800906

raylene.liu@3ebio.com

China1 site, 1 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binghe Xu, 13501028690, xubinghe@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S in Breast Cancer Patients With Leptomeningeal Metastases, With or Without Brain Parenchymal Metastases

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.

Read the detailed description

This is a single-arm, open-label study designed to evaluate the efficacy and safety of NBQ72S in patients with breast cancer leptomeningeal metastasis (with or without brain parenchymal metastasis).

Patients will undergo screening prior to study entry. After screening successfully, they will receive intravenous infusion of NBQ72S. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or any other conditions except as specified in the protocol (whichever occurs first). However, patients who demonstrate clinical benefits (despite radiological progression) with manageable toxicity, and are willing to continue receiving the NBQ72S, will be given the opportunity to continue treatment after the assessment and confirmation of Investigator.

After treatment completion, patients will undergo safety follow-up and long-term survival follow-up until death or lost to follow-up.

Conditions
Breast Cancer
Being tested
NBQ72S
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBQ72SDrug

    Also called QBS10072S

    Patients will receive the study drug every 28 days

Study groups in NCT06810804
Study groupRoleWhat they receive
Treatment GroupExperimentalAll patients reated with NBQ72S
Receives: Drug: NBQ72S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    Overall Survival

    Measured: through study completion, an average of 1.5 years

Secondary outcomes (5)

  1. Intracrarnial PFS

    Intracrarnial Progression Free Survival

    Measured: through study completion, an average of 1.5 years

  2. Intracrarnial DOR

    Intracrarnial Duration of Response

    Measured: through study completion, an average of 1.5 years

  3. Extracrarnial ORR

    Extracrarnial Objective Response Rate

    Measured: through study completion, an average of 1.5 years

  4. Extracrarnial PFS

    Extracrarnial Progression Free Survival

    Measured: through study completion, an average of 1.5 years

  5. Extracrarnial DOR

    Extracrarnial Duration of Response

    Measured: through study completion, an average of 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start22 Apr 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810804
Sponsor's protocol ID
NBQ-72S-2001
Status last verified
Apr 2026
First submitted
22 Jan 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NBQ72S in people with Breast Cancer, run by Nantong Bencao Quadriga Medical Technology Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raylene Liu (021-50800906, raylene.liu@3ebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06810804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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A Phase IIa Study to Evaluate NBQ72S (NCT06810804) | AzTrials