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Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT05305365
Recruitment Status : Not yet recruiting
First Posted : March 31, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Melanie Hayden Gephart, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Metastases Breast Cancer Drug: QBS72S Phase 2

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), and Cohort 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: QBS72S 12 mg/m2 IV injection
All participants will receive QBS72S IV injections once monthly until disease progression.
Drug: QBS72S
QBS72S 12mg/m2 injection given intravenous once a month.
Other Name: QBS10072S




Primary Outcome Measures :
  1. Overall Response against Intracranial Tumor Lesions [ Time Frame: 6 months ]
    The overall response against the target intracranial tumor lesions in Cohort 1 (Stages 1+2) participants was assessed by according to the modified Response Assessment in Neuro-oncology for Brain Metastases (mRANO-BM)

  2. RECIST 1.1 response criteria [ Time Frame: 6 months from the start of treatment ]
    Clinical response means either a complete response (CR) or a partial response (PR). CR is defined as disappearance of tumor lesions, and PR is defined as ≥ 30% reduction in diameter of tumor lesions.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 2 months ]
    Progression-free Survival (PFS) means to remain alive without tumor progression, assessed as a ≥ 25% increase in tumor diameter

  2. Overall Survival (OS) [ Time Frame: 2 months ]
    Overall survival (OS) refers to remaining alive at the time of the assessment.

  3. Duration of Response (DoR) [ Time Frame: 6 months ]
    Duration of Response (DoR) refers to length of time that a clinical response is maintained in Cohort 1 (Stages 1+2) participants.

  4. Related Adverse Events (AEs) [ Time Frame: 30 days following the last administration of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 breast cancer.
  • 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 inhibitors
    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.

Exclusion Criteria:

  • 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 situ.
  • 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 exclusion criterion.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305365


Contacts
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Contact: Monica Granucci 650-388-8906 migranucci@stanford.edu

Locations
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United States, California
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Contact: Monica Granucci    650-388-8906    migranucci@stanford.edu   
Principal Investigator: Melanie H Gephart, MD, MAS         
Sub-Investigator: Michael Iv, MD         
Sub-Investigator: Seema Nagpal, MD         
Sub-Investigator: Michael Lim, MD         
Sub-Investigator: Gordon Li, MD         
Sub-Investigator: Steven Chang, MD         
Sub-Investigator: Lawrence Shuer, MD         
Sub-Investigator: Lawrence Recht, MD         
Sub-Investigator: Reena Thomas, MD         
Sub-Investigator: Chirag Patel, MD         
Sub-Investigator: Melinda Telli, MD         
Sub-Investigator: Michelle Melisko, MD         
Sponsors and Collaborators
Melanie Hayden Gephart
Investigators
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Principal Investigator: Melanie H Gephart, MD, MAS Stanford University
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Responsible Party: Melanie Hayden Gephart, Professor of Neurosurgery, Stanford University
ClinicalTrials.gov Identifier: NCT05305365    
Other Study ID Numbers: IRB-63041
BRN0051 ( Other Identifier: OnCore )
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases