Study Assessing QBS72S For Treating Brain Metastases

NCT05305365 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB-63041BRN0051NCI-2023-00648
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Metastases; Breast Cancer; Lung Cancer; Leptomeningeal Disease; LMD

Outcome Measures

Primary Outcomes (2)

• Overall Response against Intracranial Tumor Lesions, Cohort 1 (Stages 1+2)

  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)

  6 months

• RECIST 1.1 response criteria

  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.

  6 months from the start of treatment

Secondary Outcomes (4)

• Progression-free Survival (PFS), Cohort 1 (Stages 1+2)

  2 months

• Overall Survival (OS), Cohort 1 (Stages 1+2)

  2 months

• Duration of Response (DoR), Cohort 1 (Stages 1+2)

  6 months

• Related Adverse Events (AEs)

  30 days following the last administration of study drug

Study Arms (3)

Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1)

EXPERIMENTAL

All participants in Cohort 1 will receive QBS72S IV injections once monthly until disease progression.

Drug: QBS72S

Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)

EXPERIMENTAL

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

Drug: QBS72S

Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)

EXPERIMENTAL

All participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.

Drug: QBS72S

Interventions

QBS72S DRUG

QBS72S 18mg/m2 injection given intravenous once a month.

Also known as: QBS10072S

Patients with Breast Cancer Leptomeningeal Disease (Cohort 2); Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1); Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must be 18 years or older
• The participant must have a Karnofsky Performance Status (KPS) of 60 or above.
• One of the following:
• 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.
• 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.
• One of the following:
• 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.
• 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.
• a. Cohort 3: A participant with LMD from any primary cancer site 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 3.
• For corticosteroids and anticonvulsants, the participant must either: c. not be taking any, or d. be taking stable or decreasing doses for ≥5 days prior to obtaining the screening Gd-MRI of the brain. The maximum allowable dose of corticosteroids is 8mg of dexamethasone per day, or the equivalent of another medication as assessed by a Neuro-Oncologist. Escalation of corticosteroids is not allowed ≤14 days prior to C1D1.
• The participant must have completed washout from prior therapy before C1D1, as applicable: e. ≥7 days for Ommaya placement (Cohorts 2+3) f. ≥14 days for small molecules and non-cytotoxic systemic drugs e.g., PARP inhibitors g. ≥21 days for checkpoint inhibitors and monoclonal antibodies, e.g., atezolizumab, pembrolizumab, and bevacizumab, and cytotoxic chemotherapy h. ≥28 days for investigational drugs, radiotherapy, and major surgery. Minor procedures such as tumor biopsy are allowed with written approval from the PI i. ≥1 dosing cycle for other interventions All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or have resolved. Participation in long term follow up in another clinical trial is allowed if no procedures will be performed which may interfere with the interpretation of study results.
• The participant must have adequate bone marrow function, including: j. ANC ≥ 1,500/mm3 or ≥ 1.5 x 109/L k. Platelets ≥ 100,000/ mm3 or ≥ 100 x 109/L l. Hemoglobin ≥ 9 g/dL
• The participant must have adequate renal function, including serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min. In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately.

You may not qualify if:

• 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.
• 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.
• 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.
• Participants who are pregnant or breastfeeding.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• Quadriga Biosciences, Inc.: collaborator

Study Sites (1)

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Taiwo R, Harary PM, Trinh TTH, Granucci M, Bertrand S, Carlson-Clarke B, Chernikova SB, Therkelsen K, Arora M, Melisko ME, Iv M, Vogel H, Han S, Xie C, Brain S, Lee V, Bharani KL, Nagpal S, Hayden Gephart M. Adaptive cohort design and LAT1 expression scale: study protocol for a Phase 2a trial of QBS72S in breast cancer brain metastases. BMC Cancer. 2025 Aug 15;25(1):1316. doi: 10.1186/s12885-025-14282-x.

  PMID: 40813655 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Lung Neoplasms; Meningeal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Melanie H Gephart, MD, MAS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: August 16, 2022
• Primary Completion: June 20, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)