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Study Assessing QBS72S For Treating Brain Metastases | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study Assessing QBS72S For Treating Brain Metastases

Phase IIa Study Assessing QBS72S For Treating Brain Metastases

NCT05305365•Stanford University

Summary

This study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic cancer with CNS involvement

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), Cohort 2, and Cohort 3.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The participant must be 18 years or older
•2. The participant must have a Karnofsky Performance Status (KPS) of 60 or above.
•3. One of the following:
•1. Cohorts 1 and 2: The participant must have a histologically-confirmed breast cancer primary tumor, either confirmed via primary specimen or via metastasis site, having developed brain metastases (parenchymal or LMD) after a prior cytotoxic chemotherapy regimen.
•2. Cohort 3: The participant must have a histologically cancerous primary tumor, either confirmed via primary specimen or via metastasis site, having developed brain metastases (parenchymal or LMD) after a prior cytotoxic chemotherapy regimen. There is no restriction on prior cycles of systemic therapy for any primary cancer type. Breast cancer is not excluded from Cohort 3.
•4. One of the following:
•1. Cohort 1: A participant with breast cancer brain parenchymal tumors must have at least one nonirradiated tumor ≥ 3 mm2 that can be seen on 2 or more separate acquired brain MRI sequences.
•2. Cohort 2: A participant with breast cancer primary and
•LMD must receive either:
•i. a brain MRI with contrast that supports the presence of LMD, or ii. a CSF cytology test that is either positive for or suspicious for malignancy. The presence of parenchymal brain metastases does not exclude these participants from Cohort 2.
+8 more criteria

Exclusion Criteria

•1. Participants with any other current, active malignancy unrelated to their primary cancer diagnosis, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ.
•2. 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.
•3. 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.
•4. Participants who are pregnant or breastfeeding.
•5. 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.

Locations (1)

Stanford Cancer Institute

Palo Alto, California, United States

Key Dates

Start Date

August 16, 2022

Primary Completion Date

June 20, 2025

Completion Date

December 1, 2027

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

Brain MetastasesBreast CancerLung CancerLeptomeningeal DiseaseLMD

Interventions

QBS72S

DRUG

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Non-Small-Cell Lung Cancer

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Assessing QBS72S For Treating Brain Metastases

Inclusion Criteria

Exclusion Criteria

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