Trial Search Results
Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer
This study will evaluate whether the chemotherapy agent QBS10072S,a.k.a. QBS72S, is effective and safe as a treatment for two types of brain metastases from triple negative breast cancer.
Stanford is currently accepting patients for this trial.
Melanie Hayden Gephart
- Drug: QBS72S
- The participant must have a histologically confirmed TNBC primary tumor, either
confirmed via primary specimen or via metastasis site, having developed brain
metastases (parenchymal or LM) after a prior cytotoxic chemotherapy regimen. TNBC is
defined as breast cancer that is estrogen receptor (ER)-negative (< 5% expression);
progesterone receptor (PR)-negative (< 5% expression); and human epidermal growth
factor receptor 2 (HER2)-negative (negative FISH result or a HER2 receptor IHC result
of 0 or 1+).There is no restriction on prior cycles of systemic therapy for metastatic
- One of the following:
1. A participant with brain parenchymal tumors must have at least one untreated
tumor > 3 mm2 that can be seen on 2 or more separate acquired sequences.
2. A participant with LM disease must have a positive cytology or MRI evidence of
LMD. The presence of parenchymal brain metastases does not exclude these
participants from Cohort 2.
- The participant must be 18 years old or older.
- The participant must have a Karnofsky Performance Status (KPS) of 60 or above.
- The participant must receive an MRI with contrast that supports the presence of
parenchymal brain metastases or leptomeningeal disease.
- The participant must be on stable doses of corticosteroids and anticonvulsants for
greater than or equal to 5 days prior to obtaining the baseline Gd-MRI of the brain.
- The participant must have completed treatment greater than or equal to:
1. 14 days for small molecules and non-cytotoxic systemic drugs e.g., PARP
2. 21 days for checkpoint inhibitors and monoclonal antibodies, e.g., atezolizumab,
pembrolizumab, and bevacizumab, and cytotoxic chemotherapy
3. 28 days for investigational drugs and radiotherapy; or
4. 1 dosing cycle for other interventions, prior to first dose of QBS72S All
clinically significant toxicities excluding alopecia must have resolved to less
than or equal to CTCAE v5.0 Grade 1. Participation in long term follow up 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:
1. ANC ≥ 1,500/mm3 or ≥ 1.5 x 109/L
2. Platelets ≥ 100,000/ mm3 or ≥ 100 x 109/L
3. 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:
1. Total serum bilirubin ≤ 1.5 x ULN unless the participant has documented Gilbert
syndrome who must have a total bilirubin < 3.0 mg/dl
2. 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.
- Participants currently using any anticancer therapy (including radiotherapy) or using
any investigational agent(s), except those explicitly documented allowable by the PI.
- Participants with any other active malignancy within 3 years prior to enrollment,
except for adequately treated basal cell or squamous cell skin cancer or carcinoma in
- Participants taking a dexamethasone dose greater than 8 mg per day as a stable or
decreasing dose. No escalation of dexamethasone dosing is allowed in the past 14 days
prior to screening.
- Participants who received major surgery or brain surgery within 28 days or fewer.
Minor procedures such as tumor biopsy are allowed with written approval of the PI.
- Participants with tumors within the brainstem or spinal cord parenchyma. LMD is not an
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study