Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05305365
Other study ID # IRB-63041
Secondary ID BRN0051NCI-2023-
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 16, 2022
Est. completion date August 2026

Study information

Verified date February 2024
Source Stanford University
Contact Kriti Lalwani
Phone 650-736-6489
Email kritil@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2026
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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. 5. 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. 6. 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. 7. 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 8. 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. 9. The participant must have adequate liver function, including: m. Total serum bilirubin = 1.5 x ULN unless the participant has documented Gilbert syndrome who must have a total bilirubin < 3.0 mg/dl n. Aspartate and Alanine aminotransferase (AST and ALT) = 2.5 x ULN; = 5.0 x ULN if there is liver involvement by the tumor 10. Any participant physiologically capable of becoming pregnant or getting a partner pregnant must agree to use highly effective contraception during study treatment and for 7 months after study discontinuation. 11. Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures 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-ß-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.

Study Design


Intervention

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

Locations

Country Name City State
United States Stanford Cancer Institute Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Melanie Hayden Gephart Quadriga Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Progression-free Survival (PFS), Cohort 1 (Stages 1+2) Progression-free Survival (PFS) means to remain alive without tumor progression, assessed as a = 25% increase in tumor diameter 2 months
Secondary Overall Survival (OS), Cohort 1 (Stages 1+2) Overall survival (OS) refers to remaining alive at the time of the assessment. 2 months
Secondary Duration of Response (DoR), Cohort 1 (Stages 1+2) Duration of Response (DoR) refers to length of time that a clinical response is maintained in Cohort 1 (Stages 1+2) participants. 6 months
Secondary Related Adverse Events (AEs) Toxicity refers to drug-related adverse events (AEs). The outcome is reported as the number of related AEs that were serious or non-serious, and by severity (mild, moderate, severe, life-threatening, or fatal), numbers without dispersion 30 days following the last administration of study drug
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2