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
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases Breast Cancer||Drug: QBS72S||Phase 2|
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).
- Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through progression free survival (PFS) in Cohort 1 (Stages 1+2).
- Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall survival (OS) in Cohort 1 (Stages 1+2).
- Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through durations of response (DoR) in Cohort 1 (Stages 1+2).
- Evaluate safety of QBS72S treatment in Cohort 1 (Stages 1+2), and Cohort 2.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: QBS72S 12 mg/m2 IV injection
All participants will receive QBS72S IV injections once monthly until disease progression.
QBS72S 12mg/m2 injection given intravenous once a month.
Other Name: QBS10072S
- 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)
- 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.
- 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
- Overall Survival (OS) [ Time Frame: 2 months ]Overall survival (OS) refers to remaining alive at the time of the assessment.
- 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.
- Related Adverse Events (AEs) [ Time Frame: 30 days following the last administration of study drug ]
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
|Contact: Monica Granucciemail@example.com|
|United States, California|
|Stanford Cancer Institute|
|Palo Alto, California, United States, 94305|
|Contact: Monica Granucci 650-388-8906 firstname.lastname@example.org|
|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|
|Principal Investigator:||Melanie H Gephart, MD, MAS||Stanford University|