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Brain MetastasesPhase 2NCT05305365

Study Assessing QBS72S For Treating Brain Metastases

A Phase 2 study testing QBS72S in people with Brain Metastases and Breast Cancer, run by Melanie Hayden Gephart at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic cancer with CNS involvement Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Breast Cancer, Lung Cancer
What is being tested?
QBS72S
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
16 Aug 2022to Dec 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant must be 18 years or older
  • The participant must have a Karnofsky Performance Status (KPS) of 60 or above.
  • One of the following:
  • Cohorts 1 and 2: The participant must have a histologically-confirmed breast cancer primary tumor, either confirmed via primary specimen or via metastasis site, having developed brain metastases (parenchymal or LMD) after a prior cytotoxic chemotherapy regimen.
  • Cohort 3: The participant must have a histologically cancerous primary tumor, either confirmed via primary specimen or via metastasis site, having developed brain metastases (parenchymal or LMD) after a prior cytotoxic chemotherapy regimen. There is no restriction on prior cycles of systemic therapy for any primary cancer type. Breast cancer is not excluded from Cohort 3.
  • One of the following:
Show all 18Show fewer
  • Cohort 1: A participant with breast cancer brain parenchymal tumors must have at least one nonirradiated tumor ≥ 3 mm2 that can be seen on 2 or more separate acquired brain MRI sequences.
  • Cohort 2: A participant with breast cancer primary and
  • LMD must receive either:
  • a brain MRI with contrast that supports the presence of LMD, or ii. a CSF cytology test that is either positive for or suspicious for malignancy. The presence of parenchymal brain metastases does not exclude these participants from Cohort 2.
  • Cohort 3: A participant with LMD from any primary cancer site must receive either: i. a brain MRI with contrast that supports the presence of LMD, or ii. a CSF cytology test that is either positive for or suspicious for malignancy. The presence of parenchymal brain metastases does not exclude these participants from Cohort 3.
  • For corticosteroids and anticonvulsants, the participant must either: c. not be taking any, or d. be taking stable or decreasing doses for ≥5 days prior to obtaining the screening Gd-MRI of the brain. The maximum allowable dose of corticosteroids is 8mg of dexamethasone per day, or the equivalent of another medication as assessed by a Neuro-Oncologist. Escalation of corticosteroids is not allowed ≤14 days prior to C1D1.
  • The participant must have completed washout from prior therapy before C1D1, as applicable: e. ≥7 days for Ommaya placement (Cohorts 2+3) f. ≥14 days for small molecules and non-cytotoxic systemic drugs e.g., PARP inhibitors g. ≥21 days for checkpoint inhibitors and monoclonal antibodies, e.g., atezolizumab, pembrolizumab, and bevacizumab, and cytotoxic chemotherapy h. ≥28 days for investigational drugs, radiotherapy, and major surgery. Minor procedures such as tumor biopsy are allowed with written approval from the PI i. ≥1 dosing cycle for other interventions All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or have resolved. Participation in long term follow up in another clinical trial is allowed if no procedures will be performed which may interfere with the interpretation of study results.
  • The participant must have adequate bone marrow function, including: j. ANC ≥ 1,500/mm3 or ≥ 1.5 x 109/L k. Platelets ≥ 100,000/ mm3 or ≥ 100 x 109/L l. Hemoglobin ≥ 9 g/dL
  • The participant must have adequate renal function, including serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min. In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately.
  • The participant must have adequate liver function, including: m. Total serum bilirubin ≤ 1.5 x ULN unless the participant has documented Gilbert syndrome who must have a total bilirubin < 3.0 mg/dl n. Aspartate and Alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN; ≤ 5.0 x ULN if there is liver involvement by the tumor
  • Any participant physiologically capable of becoming pregnant or getting a partner pregnant must agree to use highly effective contraception during study treatment and for 7 months after study discontinuation.
  • Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Who cannot join

  • Participants with any other current, active malignancy unrelated to their primary cancer diagnosis, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ.
  • Participants with intolerance to or who have had a severe (Grade 3) allergic or anaphylactic reaction to any of the substances included in the investigational product: sulfobutylether-β-cyclodextrin, melphalan, bendamustine, chlorambucil or any nitrogen mustard chemotherapeutics.
  • Participants who currently use or have an anticipated need for a contraindicated medication including live vaccines, natalizumab, nivolumab, ocrelizumab, palifermin, pimecrolimus, tacrolimus, tofacitinib, and EIAEDs, including phenytoin, phenobarbital, carbamazepine, fosphenytoin, primidone, and oxcarbazepine. The washout period for any live vaccine is 30 days prior to enrollment. There is no restriction for seasonal flu vaccines that do not contain live virus, nor any approved COVID vaccine.
  • Participants who are pregnant or breastfeeding.
  • Participants who have active medical or psychiatric conditions which, in the opinion of the Principal Investigator or a Sub-Investigator, would compromise or interfere with their ability to participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Cancer Institute

    Palo Alto, California, 94305

Other trials in United States

About this study

Official title: Phase IIa Study Assessing QBS72S For Treating Brain Metastases

This study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic cancer with CNS involvement

Read the detailed description

Primary Objective

  1. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall response rate (ORR) in Cohort 1 (Stages 1+2).

Secondary Objectives

  1. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through progression free survival (PFS) in Cohort 1 (Stages 1+2).
  2. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall survival (OS) in Cohort 1 (Stages 1+2).
  3. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through durations of response (DoR) in Cohort 1 (Stages 1+2).
  4. Evaluate safety of QBS72S treatment in Cohort 1 (Stages 1+2), Cohort 2, and Cohort 3.
Being tested
QBS72S
Medical subject headings
Brain Neoplasms, Breast Neoplasms, Lung Neoplasms, Meningeal Neoplasms

What participants receive

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

  • QBS72SDrug

    Also called QBS10072S

    QBS72S 18mg/m2 injection given intravenous once a month.

Study groups in NCT05305365
Study groupRoleWhat they receive
Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1, Stage 1)ExperimentalAll participants in Cohort 1 Stage 1 will receive QBS72S IV injections once monthly until disease progression.
Receives: Drug: QBS72S
Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1, Stage 2)ExperimentalAll participants in Cohort 1 Stage 2 will receive QBS72S IV injections once monthly until disease progression. This cohort never opened to enrollment
Receives: Drug: QBS72S
Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)ExperimentalAll participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.
Receives: Drug: QBS72S
Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)ExperimentalAll participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.
Receives: Drug: QBS72S

What is being measured

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

  1. Overall Response Against Intracranial Tumor Lesions, Cohort 1- Stage 1

    The overall response against the target intracranial tumor lesions in Cohort 1-Stage 1 participants was assessed by according to the modified Response Assessment in Neuro-oncology for Brain Metastases (mRANO-BM) and RECIST 1.1 response criteria. Clinical response means either a complete response (CR) or a partial response (CR). CR is defined as disappearance of tumor lesions, and PR is defined as ≥ 30% reduction in diameter of tumor lesions. The outcome is reported the number of Cohort 1- Stage 1 participants who achieved a CR or PR within 6 months from the start of treatment.

    Measured: 6 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS), Cohort 1-Stage 1

    Progression-free Survival (PFS) means to remain alive without tumor progression, assessed as a ≥ 25% increase in tumor diameter. The outcome is reported as the number of participants in Cohort 1- Stage 1 who remained alive at 2 months without tumor progression.

    Measured: 2 months

  2. Overall Survival (OS), Cohort 1- Stage 1

    Overall survival (OS) refers to remaining alive at the time of the assessment. The outcome is reported as the number of participants in Cohort 1- Stage 1 who remained alive at 2 months.

    Measured: 2 months

  3. Duration of Response (DoR), Cohort 1 - Stage 1

    Duration of Response (DoR) referred to the length of time that a clinical response was maintained in Cohort 1 (Stages 1+2) participants. Clinical response means either a complete response (CR) or a partial response (PR). CR was defined as disappearance of tumor lesions, and PR was defined as ≥30% reduction in diameter of tumor lesions. The outcome was assessed at 6 months and reported as median DoR with standard deviation for Cohort 1-Stage 1 participants who achieved a clinical response. If no participants achieved a clinical response, DoR was not evaluable.

    Measured: 6 months

  4. Related Adverse Events (AEs)

    Toxicity refers to drug-related adverse events (AEs). The outcome is reported as the number of related AEs that were serious per 21CFR§312.32 or non-serious, and by severity (mild, moderate, severe, life-threatening, or fatal), numbers without dispersion. Life-threatening events will only be those that are clinically life-threatening, and not merely a laboratory value without significant clinical symptoms.

    Measured: 30 days following the last administration of study drug, up to 1 year

Timeline

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

  1. First posted31 Mar 2022
  2. Study start16 Aug 2022
  3. Primary completion20 Jun 2025
  4. Study completionDec 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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305365
Sponsor's protocol ID
IRB-63041
Other IDs
NCI-2023-00648
Status last verified
Apr 2026
First submitted
22 Mar 2022
Last updated
20 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nagpal S, Carlson-Clarke B, Rout SS, Trinh TTH, Roy-O'Reilly M, Tedjakusuma SN, Taiwo R, Harary PM, Granucci M, Chernikova SB, Bertrand S, Therkelsen KE, Han SS, Gu B, Bharani KL, Newman JM, Barisano G, Umeh-Garcia MC, Herrick D, Vogel H, Arora M, Samos CH, Soltys SG, Pollom EL, Rahimy E, Iv M, Melisko ME, Hayden Gephart M. Phase 2 test of QBS72S for breast cancer leptomeningeal disease. Neuro Oncol. 2026 Aug 7:noag177. doi: 10.1093/neuonc/noag177. Online ahead of print.

    PubMed 42565554

  • Taiwo R, Harary PM, Trinh TTH, Granucci M, Bertrand S, Carlson-Clarke B, Chernikova SB, Therkelsen K, Arora M, Melisko ME, Iv M, Vogel H, Han S, Xie C, Brain S, Lee V, Bharani KL, Nagpal S, Hayden Gephart M. Adaptive cohort design and LAT1 expression scale: study protocol for a Phase 2a trial of QBS72S in breast cancer brain metastases. BMC Cancer. 2025 Aug 15;25(1):1316. doi: 10.1186/s12885-025-14282-x.

    PubMed 40813655

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QBS72S in people with Brain Metastases and Breast Cancer, run by Melanie Hayden Gephart at 1 site in United States.

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 18 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 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 United States. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Against Intracranial Tumor Lesions, Cohort 1- Stage 1 (time frame: 6 months). 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 NCT05305365, which also lists 2 linked publications.

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 20 Oct 2026.

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