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QBS72S for Brain Cancer from Breast Cancer
Phase 2
Recruiting
Led By Melanie H Gephart, MD, MAS
Research Sponsored by Melanie Hayden Gephart
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether a new chemotherapy agent is effective and safe in treating brain metastases from triple negative breast cancer.
Who is the study for?
Adults with advanced breast cancer that has spread to the brain, who've had prior chemotherapy. They must be able to consent, follow study procedures, and have good organ function and performance status. Contraception is required for those who can conceive. Exclusions include recent major surgery, certain medical conditions or treatments, high steroid doses, severe drug allergies, other active cancers within 3 years (except some skin cancers), pregnancy/breastfeeding.Check my eligibility
What is being tested?
The trial tests QBS72S's effectiveness and safety in treating brain metastases from breast cancer. Participants will receive this investigational drug after completing previous treatments including chemo and radiotherapy as per specified waiting periods.See study design
What are the potential side effects?
While specific side effects of QBS72S are not listed here, similar drugs may cause allergic reactions or issues related to the components like sulfobutylether-β-cyclodextrin or nitrogen mustard chemotherapeutics which could lead to various organ-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response against Intracranial Tumor Lesions, Cohort 1 (Stages 1+2)
RECIST 1.1 response criteria
Secondary outcome measures
Duration of Response (DoR), Cohort 1 (Stages 1+2)
Overall Survival (OS), Cohort 1 (Stages 1+2)
Progression-free Survival (PFS), Cohort 1 (Stages 1+2)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)Experimental Treatment1 Intervention
All participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.
Group II: Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1)Experimental Treatment1 Intervention
All participants in Cohort 1 will receive QBS72S IV injections once monthly until disease progression.
Group III: Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)Experimental Treatment1 Intervention
All participants in Cohort 2 will receive QBS72S IV injections once monthly until disease progression.
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Who is running the clinical trial?
Melanie Hayden GephartLead Sponsor
Quadriga Biosciences, Inc.Industry Sponsor
2 Previous Clinical Trials
265 Total Patients Enrolled
Melanie H Gephart, MD, MASPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active cancer other than my primary diagnosis, except for treated skin cancer or carcinoma in situ.My bone marrow is functioning well.I meet the requirements for corticosteroid and anticonvulsant use.I am currently using, or might need, medications that are not allowed in the trial.My breast cancer has spread to my brain after chemotherapy.I am mostly able to care for myself but may need occasional help.I am 18 years old or older.My liver is functioning well.My kidneys are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1)
- Group 2: Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)
- Group 3: Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is QBS72S to human health?
"There is limited evidence suggesting QBS72S's safety, giving it a rating of 2. However, there are no findings to support the drug's efficacy yet."
Answered by AI
How many participants are involved in the current clinical research?
"Yes, the information hosted on clinicaltrials.gov confirms that this medical trial is actively engaging patients; it was initially posted on August 16th 2022 and its most recent update took place October 13th of that same year. The study requires 35 participants to be sourced from a single site."
Answered by AI
Are there any vacancies available for this clinical experiment?
"The clinical trial is currently open to applicants, as referenced on the official website. This study was initially posted in August of 2022 and underwent its most recent update earlier this month."
Answered by AI
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