QBS72S for Brain Cancer from Breast Cancer

Overseen By Sahara Rout

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Live vaccines, EIAEDs

Disqualifiers: Active malignancy, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called QBS72S for individuals with brain cancer originating from breast cancer or other cancers. The trial aims to evaluate the treatment's effectiveness and safety for those whose cancer has spread to the brain and returned after other treatments. Participants include individuals with breast cancer that has resulted in brain tumors or leptomeningeal disease (cancer in the layers covering the brain and spinal cord). Ideal candidates have already undergone some cancer treatments and experience frequent brain-related issues due to their condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for some drugs before starting. You may need to stop certain medications like small molecules, non-cytotoxic drugs, and others for a specific time before joining. Check with the trial team to see if your current medications are affected.

Is there any evidence suggesting that QBS72S is likely to be safe for humans?

Research shows that QBS72S is being tested for safety and effectiveness in treating brain cancer that has spread from breast cancer. Earlier studies suggest that QBS72S could benefit patients with cancer that has metastasized to the brain. These studies aim to determine the treatment's safety and patient tolerance.

So far, no major side effects have been commonly reported, suggesting that QBS72S might be well-tolerated. However, because QBS72S is still under investigation, complete safety information is not yet available. The current trial is part of ongoing research to learn more about its safety and potential side effects.

Prospective participants should consult healthcare providers to understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain cancer?

QBS72S is unique because it targets brain metastases from breast cancer, which is a challenging condition to treat. Unlike many current therapies that might involve surgery, radiation, or traditional chemotherapy, QBS72S is administered through monthly IV injections, offering a more targeted approach. Researchers are excited because this treatment could potentially penetrate the blood-brain barrier more effectively, delivering the drug directly to the cancer cells in the brain and potentially improving outcomes for patients with brain metastases and leptomeningeal disease.

What evidence suggests that QBS72S might be an effective treatment for brain cancer from breast cancer?

Research has shown that QBS72S is being tested to treat brain metastases, which are cancer cells that have spread to the brain. Early results suggest that QBS72S might help stop or slow the growth of these cancer cells. This trial studies QBS72S in people with breast cancer that has spread to the brain (Cohort 1) or the lining around the brain and spinal cord, known as leptomeningeal disease (Cohort 2). Additionally, it is being tested in patients with any primary cancer that has resulted in leptomeningeal disease (Cohort 3). Initial studies focus on how well the treatment works in shrinking or eliminating the cancer. The aim is to see if QBS72S can help manage these difficult conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Melanie H Gephart, MD, MAS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participant must have completed washout from prior therapy as applicable

My bone marrow is functioning well.

I meet the requirements for corticosteroid and anticonvulsant use.

Exclusion Criteria

I have no active cancer other than my primary diagnosis, except for treated skin cancer or carcinoma in situ.

I am currently using, or might need, medications that are not allowed in the trial.

Participants with intolerance or severe allergic reactions to specific substances in the investigational product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QBS72S IV injections once monthly until disease progression

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• QBS72S

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

All participants in Cohort 2 will receive QBS72S IV injections once monthly until disease progression.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Melanie Hayden Gephart

Lead Sponsor

Trials

1

Recruited

40+

Quadriga Biosciences, Inc.

Industry Sponsor

Trials

3

Recruited

520+

Published Research Related to This Trial

DZD1516 is a promising HER2 inhibitor that effectively penetrates the blood-brain barrier and shows selectivity for HER2 over wild-type EGFR, making it a potential treatment for HER2-positive metastatic breast cancer with CNS metastases.

In a phase 1 trial involving 23 patients, DZD1516 demonstrated a maximum tolerated dose of 250 mg twice daily, with manageable side effects and stable disease as the best antitumor response, indicating its potential for further clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical and clinical activity of DZD1516, a full blood-brain barrier-penetrant, highly selective HER2 inhibitor. Zhang, J., McAndrew, NP., Wang, X., et al.[2023]

The glycoprotein pMQ1 is commonly found in breast cancer tissues but absent in normal and benign breast tissues, indicating its potential role as a tumor marker.

Higher levels of pMQ1 are associated with worse outcomes, including higher histological grades and increased likelihood of local recurrence, suggesting it may serve as a prognostic indicator in breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic significance of glycoprotein pMQ1 in breast cancer. Fon, LJ., Lioe, TF., Mulligan, KA., et al.[2006]

In a study of 473 patients with metastatic breast cancer, 15.6% developed central nervous system (CNS) metastases, with a median survival of 7.53 months after diagnosis.

The risk of developing CNS metastases was notably higher in patients with aggressive breast cancer subtypes, particularly grade 3, hormone receptor-negative, HER2-positive cancers, while HER2-positive patients had better survival outcomes compared to those without locoregional treatment or with multiple CNS lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and survival outcomes in patients with brain metastases from breast cancer. Minisini, AM., Moroso, S., Gerratana, L., et al.[2022]

A novel screening method identified two compounds, Ch-1 and Ch-2, that effectively reduced brain tumor burden and increased survival by over 10 days in a mouse model of breast cancer metastasis to the brain.

Ch-1 works by preventing the activation of pro-survival pathways in cancer cells, suggesting a specific mechanism of action that could enhance treatment efficacy against brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Novel Agents for the Treatment of Brain Metastases of Breast Cancer. Venishetty, VK., Geldenhuys, WJ., Terell-Hall, TB., et al.[2018]

Trastuzumab has significantly improved treatment outcomes for advanced breast cancer patients with tumors that overexpress the ErbB2 (HER2) protein, but it has also led to an increased incidence of brain metastases in these patients.

Lapatinib, a targeted therapy that inhibits ErbB1 and ErbB2, shows promise as a potential treatment option for managing brain metastases in patients with ErbB2-positive breast cancer, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New challenges and opportunities in the management of brain metastases in patients with ErbB2-positive metastatic breast cancer. Melisko, ME., Glantz, M., Rugo, HS.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40813655/

study protocol for a Phase 2a trial of QBS72S in breast cancer ... Up to 30% of patients with breast-to-brain metastases will develop leptomeningeal disease (LMD), with poor survival, rapid neurologic decline, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05305365

Study Assessing QBS72S For Treating Brain Metastases Primary Objective. 1. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall response rate (ORR) in Cohort 1 ...

3. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/s/NCT05305365.html

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.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00648

QBS72S for the Treatment of Brain Metastases in Patients ... This phase II trial tests how well QBS72S works in treating patients with breast cancer that has spread from where it first started (primary site) to the ...

5. bioengineer.org bioengineer.org/adaptive-trial-explores-qbs72s-for-brain-mets/

Adaptive Trial Explores QBS72S for Brain Mets In summary, the Phase 2a study of QBS72S represents a critical juncture in breast cancer brain metastasis research, combining molecular ...

6. synapse.patsnap.com synapse.patsnap.com/drug/acfa79fd99a349ab883a1e07945d2ad4

QBS-10072S - Drug Targets, Indications, Patents 1 About the Study The Phase 2 open-label clinical trial is designed to assess the safety, tolerability and efficacy of QBS72S in patients with brain metastases ...