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.
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.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe Xu, 13501028690, xubinghe@medmail.com.cn
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 group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | All patients reated with NBQ72S Receives: Drug: NBQ72S |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: through study completion, an average of 1.5 years
Secondary outcomes (5)
Intracrarnial PFS
Intracrarnial Progression Free Survival
Measured: through study completion, an average of 1.5 years
Intracrarnial DOR
Intracrarnial Duration of Response
Measured: through study completion, an average of 1.5 years
Extracrarnial ORR
Extracrarnial Objective Response Rate
Measured: through study completion, an average of 1.5 years
Extracrarnial PFS
Extracrarnial Progression Free Survival
Measured: through study completion, an average of 1.5 years
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.
- First posted6 Feb 2025
- Study start22 Apr 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nantong Bencao Quadriga Medical Technology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06810804
- Acronym / sponsor ID
- NBQ-72S-2001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nantong Bencao Quadriga Medical Technology Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: NBQ72SAll patients reated with NBQ72S |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- The patient must have adequate renal function, including:
- The patient must have adequate hepatic function, including:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBQ72SAlso: QBS10072SPatients will receive the study drug every 28 days | Drug | Treatment Group |
Primary outcome
OS
Time frame: through study completion, an average of 1.5 years
Overall Survival
5 secondary outcomes
Intracrarnial PFS
Time frame: through study completion, an average of 1.5 years
Intracrarnial DOR
Time frame: through study completion, an average of 1.5 years
Extracrarnial ORR
Time frame: through study completion, an average of 1.5 years
Extracrarnial PFS
Time frame: through study completion, an average of 1.5 years
Extracrarnial DOR
Time frame: through study completion, an average of 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
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?
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.