A Study Comparing Immunopheresis® Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Treatment of Advanced Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    170
  • sponsor
    Immunicom Inc
Updated on 5 April 2022

Summary

This is a multicenter, open-label, Phase 1/ 2 study to evaluate the short-term and longer-term safety, tolerability, and effectiveness of Immunopheresis® with the LW-02 column in removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) from plasma of patients with advanced, refractory Breast Cancer (BC) and for disease control when employed as monotherapy, or in combination with a low dose chemotherapy. A low dose chemotherapy will serve as control.

Description

This is a multicenter, open-label, Phase 1/ 2 study to evaluate the short-term and longer-term safety, tolerability, and effectiveness of Immunopheresis® with the LW-02 column in removal of sTNF-Rs from plasma of patients with advanced, refractory BC and for disease control when employed as monotherapy, or in combination with a low dose chemotherapy. A low dose chemotherapy will serve as control.

Part A (n=10 evaluable patients): Overall safety, tolerability, and sTNF-R-removal effectiveness of LW-02 device-based immunopheresis monotherapy conducted 3 times per week for 4 weeks in patients with advanced TNBC. This part is already completed.

Part B/Part B Extension (n = up to 30 evaluable patients): Overall safety, tolerability, and sTNF-Rs-removal effectiveness of LW-02 device-based Immunopheresis® 3 times per week for up to 16 weeks combined with low dose chemotherapy in patients with advanced refractory BC..

Part C (3 treatment arms; n=50 patients per treatment arm): Randomized comparison of overall safety, tolerability, and clinical efficacy effectiveness of (i) Immunopheresis® monotherapy with the LW-02 column 3 times per week for 16 weeks, (ii) or Immunopheresis® in combination with low dose chemotherapy, and (iii) plain low dose chemotherapy.

Safety Endpoints

  1. Safety and tolerability - incidence of Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs) and Unanticipated Serious Adverse Device Effects (USADEs) related to immunopheresis procedure as well as Adverse Events (AE) and Serious Adverse Events (SAEs).
  2. Safety endpoints of special interest - incidence of tumor lysis syndrome, and systemic inflammatory response syndrome.
  3. Patient-Reported Outcomes to evaluate health status and Quality of Life (QoL) instruments for patients with BC:
    • Eastern Cooperative Oncology Group (ECOG) status
    • EQ-5D-5L index-based scale
    • EORTC: QLQ-BR23 (breast), and QLQ-C30 (general cancer questionnaire)
    • 6-minute walk test and BORG dyspnea, fatigue scale and hand grip test
    • Nutritional status will be assessed with PG-SGA scale and via laboratory assessments of changes in serum albumin and CRP

Efficacy Endpoints

  1. Column efficiency and effectiveness in removal of sTNF-Rs from patient plasma without clinically-meaningful leaching of capture ligand (SC-TNF-α) - change in sTNF-R and TNF-α plasma levels from initiation to the end of each Immunopheresis® procedure, including pre- and post-column measurements, between each treatment, and from baseline to end of a treatment cycle (4 weeks - Part A and B/B-extension, or 16 weeks - Part C).
  2. Clinical endpoints - response in tumor burden - progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), duration of clinical benefit (DOCB), time-to-progression (TTP) and overall survival (OS). Serial evaluation of tumor burden/tumor growth is assessed according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Details
Condition Advanced Breast Cancer
Treatment Chemotherapy Drugs, Cancer, Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy
Clinical Study IdentifierNCT04004910
SponsorImmunicom Inc
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
Age ≥ 18 years female
Able to comply with the study protocol in the investigator's judgment
Histologically confirmed diagnosis of BC
Inoperable locally-advanced or metastatic disease
Must be able to provide archival pathological material from primary or metastatic site
(formalin-fixed paraffin embedded [FPPE] tissue block) for central BC confirmation and
verification of BC subtype and tmTNF expression
Adequate organ function
Weight ≥ 35 kg
Life expectancy of at least 3 months with malignancy; expected to live for one year
without malignancy
Hemoglobin ≥ 9.5g/dL (may be achieved with transfusion support)
Absolute Granulocyte Count (ANC) ≥1.5 × 109/L (without granulocyte colony-
stimulating factor support within 2 weeks prior to the first study treatment)
Platelets (PTL) ≥ 100 × 109/L
AST/ALT ≤2.5× ULN (patients with documented liver metastases: AST and/or ALT ≤ 5
Patients receiving therapeutic anticoagulation agents must be on a stable dose
× ULN; patients with documented liver or bone metastases: alkaline phosphatase ≤
Calcium level within normal ranges
×ULN)
Serum creatinine (S-Cr) ≤ 1.5
Measurable disease, as defined by RECIST v1.1
Albumin ≥ LLN
ECOG performance status 0, 1 or 2
Bilirubin ≤ 1.5 ULN
International normalized ratio (INR) and activated partial thromboplastin time
(aPTT) ≤ 1.5 × ULN. This applies only to patients who are not receiving
therapeutic anticoagulation agents
The last dose of prior systemic anticancer therapy must have been administered ≥ 7
days prior to study treatment initiation
Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT
or MRI evaluation during screening and prior radiographic evaluation, are eligible
For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use double barrier contraceptive methods that result in a
failure rate of < 1% per year during the treatment period and for at least 6 months
after the last dose of chemotherapy
Patients must have recovered (i.e., improvement to Grade 1 or better) from all acute
toxicities from previous therapy, excluding alopecia. If a patient was previously
treated with taxanes, the patient must have recovered from any adverse effects or
remain at an acceptable level for patient (i.e. peripheral neuropathy)

Exclusion Criteria

Symptomatic CNS metastases
Leptomeningeal disease
Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
Patient with known persistent, uncontrolled hypotension
Significant renal disorder requiring dialysis or indication for renal transplant
Active infection
Patients in whom vascular access is not considered achievable
Subjects with brain metastases at screening must have clinically controlled neurologic
symptoms and have received previous adequate treatment, defined as surgical excision
and/or radiation therapy with stable neurologic function and no evidence of CNS
disease progression as determined by comparing a computed tomography (CT) scan or
magnetic resonance imaging (MRI) scan performed during screening to a prior scan
performed at least 4 weeks earlier and provided that the subject is asymptomatic, has
no evidence of cavitation or hemorrhage, and does not require corticosteroids
Pregnant or lactating or intending to become pregnant during the study - women who are
not postmenopausal (postmenopausal defined as ≥ 12 months of non-drug-induced
amenorrhea) or surgically sterile must have a negative serum pregnancy test result
within 2 weeks prior to initiation of study treatment
Evidence of significant uncontrolled concomitant disease that could affect compliance
with the protocol, including significant liver disease (such as cirrhosis
uncontrolled major seizure disorder, or superior vena cava syndrome)
Significant cardiovascular disease, such as New York Heart Association cardiac disease
≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable
angina
Patients with known coronary artery disease or left ventricular ejection fraction <
% must be on a stable medical regimen that is optimized in the opinion of the
treating physician, in consultation with a cardiologist if appropriate
Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to study treatment initiation
Major surgical procedure within 4 weeks prior to study treatment initiation or
anticipation of need for a major surgical procedure during the course of the study
other than for diagnosis
Fever, or any active immunosuppressive systemic infection including history of human
immunodeficiency virus (HIV) infection
Other serious diseases (e.g., life expectancy less than 3 months) including active
second malignancy except for basal cell carcinoma or cervical carcinoma in situ
Use of any standard high dose or low dose chemotherapy or immunosuppressive therapies
and or standard radiation therapy concurrently as well anticipated need for any of the
former during the study
Body mass index (BMI) ≥ 35 kg/m2
Any condition that the patient's physician determines to be detrimental to the patient
participating in this study; including any clinically important deviations from normal
clinical laboratory values or concurrent medical events
Inability to understand the local language for use of the patient QOL instruments
(EQ-5D-5L and others)
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