QBS72S for Brain Cancer from Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Melanie H Gephart, MD, MAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Melanie Hayden Gephart

Must not be taking: Live vaccines, EIAEDs

Disqualifiers: Active malignancy, Allergic reactions, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called QBS72S for people with advanced breast cancer that has spread to the brain. The goal is to see if this drug can shrink brain tumors and help patients live longer. Researchers are also checking if the drug is safe for these patients.

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.

What makes the drug QBS72S unique for treating brain cancer from breast cancer?

QBS72S is unique because it is designed to penetrate the blood-brain barrier (a protective shield around the brain that blocks many drugs), which is a major challenge in treating brain metastases from breast cancer. This ability may allow it to effectively target and treat cancer cells in the brain, unlike many other treatments that struggle to reach these areas.

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Eligibility Criteria

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

Trial Timeline

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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford Cancer Institute Palo Alto, CA

Who Is Running the Clinical Trial?

Melanie Hayden Gephart Lead Sponsor

Quadriga Biosciences, Inc. Industry Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Risk factors and survival outcomes in patients with brain metastases from breast cancer. [2022] Development of central nervous system (CNS) metastases in breast cancer (BC) is associated with poor prognosis. The incidence of CNS metastases in metastatic BC is reported to be about 10-16 %, but different subtypes of BC are associated with different risk of developing CNS metastases. We retrospectively analysed the risk of CNS metastases and the outcome in a cohort of 473 patients with metastatic BC. CNS metastases were diagnosed in 15.6 % of patients and median survival from diagnosis of CNS metastases was 7.53 (25th-75th 2.8-18.9) months. The risk of developing CNS metastases was higher in patients with grade 3, hormone receptor negative, HER2-positive, high Ki-67 BC. When compared to luminal A subtype, only HER2-positive BC was associated with increased risk of CNS metastases. Survival from diagnosis of CNS metastases was longer in patients with HER2-positive BC, while it was shorter in patients that did not receive any locoregional treatment, or with extra-CNS disease, or with more than 3 CNS lesions.

2. England pubmed.ncbi.nlm.nih.gov

Prognostic significance of glycoprotein pMQ1 in breast cancer. [2006] A novel glycoprotein, pMQ1, is positively correlated with increasing histological grade in malignant astrocytomas. Cerebral metastases from breast cancer have also been found to contain pMQ1-positive cells. This study aimed to determine the role of pMQ1 in primary breast cancer.

3. England pubmed.ncbi.nlm.nih.gov

Preclinical and clinical activity of DZD1516, a full blood-brain barrier-penetrant, highly selective HER2 inhibitor. [2023] Patients with HER2-positive metastatic breast cancer (MBC) are at high risk of developing central nervous system (CNS) metastases. A potent and selective HER2 inhibitor with good blood-brain barrier (BBB) penetration is highly desirable.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of Novel Agents for the Treatment of Brain Metastases of Breast Cancer. [2018] Brain cancer from metastasized breast cancer has a high mortality rate in women. The treatment of lesions is hampered in large part by the blood-brain barrier (BBB), which prevents adequate distribution of anti-cancer compounds to brain metastases.

5. England pubmed.ncbi.nlm.nih.gov

New challenges and opportunities in the management of brain metastases in patients with ErbB2-positive metastatic breast cancer. [2018] The introduction of trastuzumab for the treatment of tumors that overexpress ErbB2 (also known as HER2) has contributed significantly to recent improvements in systemic therapy for advanced breast cancer. The advances in systemic therapy have highlighted an increasing prevalence of central nervous system involvement in patients with ErbB2-positive breast cancer and a consequent need for new treatment options for brain metastases. Just as ErbB2-targeted systemic therapy has given rise to this challenge, so too could targeted therapy represent an opportunity to meet it. This Review considers the potential for targeted therapy to facilitate effective management of brain metastases in patients with ErbB2-positive breast cancer, and discusses in particular the data currently available in this setting for lapatinib, an orally available small-molecule tyrosine kinase inhibitor of ErbB1 and ErbB2.