Advanced Breast CancerPhase 1/2NCT04004910
A Study Comparing Immunopheresis® Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Treatment of Advanced Breast Cancer Patients
A Phase 1/2 study testing Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy and Chemotherapy Drugs, Cancer in people with Advanced Breast Cancer, run by Immunicom Inc at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy and Chemotherapy Drugs, Cancer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 31 May 2019to 31 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- Weight ≥ 35 kg
- Life expectancy of at least 3 months with malignancy; expected to live for one year without malignancy.
- Adequate organ function:
- 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 × ULN; patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 ×ULN)
- Serum creatinine (S-Cr) ≤ 1.5
- Albumin ≥ LLN
- 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.
- Patients receiving therapeutic anticoagulation agents must be on a stable dose
- Calcium level within normal ranges.
- The last dose of prior systemic anticancer therapy must have been administered ≥ 7 days prior to study treatment initiation
- Measurable disease, as defined by RECIST v1.1
- ECOG performance status 0, 1 or 2.
- 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).
Who cannot join
- Symptomatic CNS metastases
- 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;
- Leptomeningeal disease
- Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- 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)
Show all 20Show fewer
- 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 < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- Patient with known persistent, uncontrolled hypotension
- Significant renal disorder requiring dialysis or indication for renal transplant
- 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
- Active infection
- Patients in whom vascular access is not considered achievable
- 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).
Trial locations and contacts
5 sites in 2 countries.
Adam Ostrowski,MD Medical Director, International - Immunicom, Inc. contact
Robert Segal,MD, FACP Chief Medical Officer - Immunicom, Inc. contact
5 sites in 2 countries
Poland4 sites, 3 recruiting
- Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
Prof. Tomasz Nowikiewicz, MD, PhD, nowikiewicz@co.bydgoszcz.pl
- Recruiting
Katedra i Klinika Onkologii UJ CM
Krakow, Lesser Poland Voivodeship, 30-688
Prof. Piotr Wysocki, MD, PhD, +48(12)4248912, klinikaonkologii@su.krakow.pl ; onko@cm-uj.krakow.pl
Alina Wadas, +48 782780374
- Recruiting
Klinika Pneumonologii, Onkologii i Alergologii SPSK Nr 4 w Lublinie
Lublin, 20-954
Tomasz Jankowski, MD, PhD, +48 602 405 127, tjankowski.onkolog@wp.pl
- Suspended
Centrum Medyczne Pratia Poznań
Skórzewo, 60-185
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Altunizade Acıbadem Hospital
Istanbul, Uskudar, 34662
Gül Başaran, Prof.Dr., +902166494542, gul.basaran@acibadem.edu.tr
Belma Kurdoğlu Akgün, Msc, PhD, (0212) 304 44 44 ext. 470, belma.kurdoglu@acibadem.com
About this study
Official title: A Multicenter, Open-Label, Three-Part Study to Evaluate the Safety and Effectiveness of Immunopheresis With Immunicom's LW-02 Device in Removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) as Well as Clinical Efficacy in Treatment of Patients With Advanced, Refractory Breast Cancer (BC) Alone, or in Combination With Low Dose Chemotherapy Versus Low Dose Chemotherapy.
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.
Read the detailed 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
- 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).
- Safety endpoints of special interest - incidence of tumor lysis syndrome, and systemic inflammatory response syndrome.
- 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
- 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).
- 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).
- Conditions
- Advanced Breast Cancer
- Being tested
- Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy, Chemotherapy Drugs, Cancer
- Keywords
- Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma soluble TNF receptor pulldownOther
The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
Plasma soluble TNF receptor pulldown + chemotherapyOther
The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
In combined treatment arm the Immunopheresis® procedure is combined with low dose chemotherapy to potentially enhancing the latter's cytotoxic effect.
Chemotherapy Drugs, CancerDrug
Low dose chemotherapy will be provided to patient either IV or oraly depending on the regimen used.
| Study group | Role | What they receive |
|---|---|---|
| Immunopheresis® - Arm 1 | Experimental | All patients will receive up to 16 weeks of initial treatment as per study arm assignment, which will include up to 48 LW-02 column-based Immunopheresis® treatments over a 4-month period (up to 3 procedures per week) though treatment can be extended based on certain protocol-specfied conditions. Each patient assigned to the treatment with LW-02 column-based Immunopheresis® will require central vascular access for the procedure. This part is alrady completed. Receives: Other: Plasma soluble TNF receptor pulldown |
| Immunopheresis® combined with low dose chemotherapy - Arm 2 | Experimental | All patients will receive up to 16 weeks of treatment as per study arm assignment, which will include up to 48 LW-02 column-based Immunopheresis® treatments over a 4-month period (up to 3 procedures per week) though treatment can be extended based on certain protocol-specfied conditions. Each patient will require central vascular access for the procedure. Patients also will receive a low dose chemotherapy regimen administered iv or oraly. Patients treated with combination will be administered their chemotherapy following the first LW-02 column-based Immunopheresis® procedure of each week starting from week 2, assuming first week of study treatment serves as a run-in period confirming good tolerance of Immunopheresis® alone. Receives: Other: Plasma soluble TNF receptor pulldown + chemotherapy |
| Chemotherapy - Arm 3 | Active comparator | Patients who are assigned chemotherapy arm of the study will be treated with low dose chemotherapy alone. The chemotherapy will be administered intravenously or oraly depending on the regimen used. Receives: Drug: Chemotherapy Drugs, Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble Tumor Necrosis Factor Receptor (sTNFR) concentrations in plasma (picogram per mL)
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, or 16 weeks - Part C).
Measured: 16 weeks
Safety and Tolerability Assessment
Safety and tolerability assessment based on adverse event / serious adverse event (AE / SAE) and adverse device / serious adverse device effects (ADE / SADE) reporting using CTCAE/MedDRA coding terms
Measured: 16 weeks
Safety endpoints of special interest assessment
Incidence of tumor lysis syndrome and systemic inflammatory response syndrome.
Measured: 16 weeks
Clinical endpoint - overall survival
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Overall Survival (OS). Overall survival ( OS ) is defined as the time from randomization to death from any cause, is adirect measure of clinical benefit to a patient.
Measured: 16 weeks
Clinical endpoint - progression free survival
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Progression Free Survival (PFS) Progression-free survival ( pfs ) is defined as time from randomization until firstevidence of tumour progression or until death from any cause, whichever comes first.
Measured: 16 weeks
Clinical endpoint - disease control rate
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Disease Control Rate (DCR) Overall response rate (ORR) is defined as the proportion of patients who have a partialor complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.In contrast, disease control rate is a composite of ORR and stable disease and is useful to measure the efficacy oftherapies that have tumoristatic effects rather than tumoricidal effects.
Measured: 16 weeks
Secondary outcomes (7)
Nutritional status
Nutritional status will be assessed with PG-SGA scale and via laboratory assessments of changes in serum albumin and CRP concentration. The Scored Patient-Generated Subjective Global Assessment (PG-SGA©) scale will be used. The Scored PG-SGA©includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities andFunction - also known as the PG-SGA Short Form©), the professional part (Diagnosis, Age, Metabolic stress, andPhysical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition,C = severely malnourished) and the total numerical score
Measured: 16 weeks
Patient functioninig with Eastern Cooperative Oncology Group (ECOG)
Eastern Cooperative Oncology Group (ECOG) scale describes patient's functioning in terms of ability to care forthemselves, daily activity, and physical ability (walking, working). The scale grades 0 to 5 (0=fully active while 5=dead).
Measured: 16 weeks
Quality-of-life (QoL) Assessment with EQ-5D-5L scale
EQ-5D-5L scale to assess: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimensionhas 5 levels:from no problems to extreme problems.
Measured: 16 weeks
Quality-of-life (QoL) Assessment with EORTC-QLQ-C30 scale
EORTC-QLQ-C30 scale measures cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, fivefunctioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. All of the scales and single-item measures range in score from 0 to 100.Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better stateof the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. aworse state of the patient).
Measured: 16 weeks
Quality-of-life (QoL) Assessment with EORTC: QLQ-BR23
EORTC: QLQ-BR23 (breast) measuring the quality of life in patients with breast cancer. Each dimension in the scale has four response levels from not at all (1) to very much (4).
Measured: 16 weeks
Physical performance status assessment with 6 minute walk test (6MWT)
The physical performance assessment will be measured with 6-minute walk test (6MWT). 6MWT meassures the distance patient covers when walking in a regular pace in standardized condition. The longerdistance is expected in patients who improve while the poor patient performance and capability, the shorter distancewill be measured.
Measured: 16 weeks
Muscle performance assessment with a hand grip test
The muscle performance assessment will be measured hand grip test. The purpose of this test is to measurethe maximum isometric strength of the hand and forearm muscles. The participant will be asked to squeeze thedynamometer as hard as possible with each of his or her hands in a standing position. The subject squeezes thedynamometer with maximum isometric effort, which is maintained for about 5 seconds. Results for left and right handseparately are recorded in kilograms.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start31 May 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Open-Label, Three-Part Study
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunicom Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Ostrowski, MD, Study director, Immunicom Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004910
- Sponsor's protocol ID
- CP7-005
- Status last verified
- Mar 2022
- First submitted
- 24 Jun 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Three-Part Study to Evaluate the Safety and Effectiveness of Immunopheresis With Immunicom's LW-02 Device in Removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) as Well as Clinical Efficacy in Treatment of Patients With Advanced, Refractory Breast Cancer (BC) Alone, or in Combination With Low Dose Chemotherapy Versus Low Dose Chemotherapy.
- ClinicalTrials.gov ID
- NCT04004910
- Acronym / sponsor ID
- CP7-005
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Immunicom IncIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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).
- Safety endpoints of special interest - incidence of tumor lysis syndrome, and systemic inflammatory response syndrome.
- 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
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Multicenter, Open-Label, Three-Part Study
| Arm | Type | Receives |
|---|---|---|
| Immunopheresis® - Arm 1 | Experimental | Other: Plasma soluble TNF receptor pulldownAll patients will receive up to 16 weeks of initial treatment as per study arm assignment, which will include up to 48 LW-02 column-based Immunopheresis® treatments over a 4-month period (up to 3 procedures per week) though treatment can be extended based on certain protocol-specfied conditions. Each patient assigned to the treatment with LW-02 column-based Immunopheresis® will require central vascular access for the procedure. This part is alrady completed. |
| Immunopheresis® combined with low dose chemotherapy - Arm 2 | Experimental | Other: Plasma soluble TNF receptor pulldown + chemotherapyAll patients will receive up to 16 weeks of treatment as per study arm assignment, which will include up to 48 LW-02 column-based Immunopheresis® treatments over a 4-month period (up to 3 procedures per week) though treatment can be extended based on certain protocol-specfied conditions. Each patient will require central vascular access for the procedure. Patients also will receive a low dose chemotherapy regimen administered iv or oraly. Patients treated with combination will be administered their chemotherapy following the first LW-02 column-based Immunopheresis® procedure of each week starting from week 2, assuming first week of study treatment serves as a run-in period confirming good tolerance of Immunopheresis® alone. |
| Chemotherapy - Arm 3 | Active comparator | Drug: Chemotherapy Drugs, CancerPatients who are assigned chemotherapy arm of the study will be treated with low dose chemotherapy alone. The chemotherapy will be administered intravenously or oraly depending on the regimen used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (20 listed)
- Symptomatic CNS metastases
- 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;
- Leptomeningeal disease
- Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma soluble TNF receptor pulldownThe Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. | Other | Immunopheresis® - Arm 1 |
| Plasma soluble TNF receptor pulldown + chemotherapyThe Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the Immunopheresis® procedure is combined with low dose chemotherapy to potentially enhancing the latter's cytotoxic effect. | Other | Immunopheresis® combined with low dose chemotherapy - Arm 2 |
| Chemotherapy Drugs, CancerLow dose chemotherapy will be provided to patient either IV or oraly depending on the regimen used. | Drug | Chemotherapy - Arm 3 |
Primary outcome
Soluble Tumor Necrosis Factor Receptor (sTNFR) concentrations in plasma (picogram per mL)
Time frame: 16 weeks
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, or 16 weeks - Part C).
Safety and Tolerability Assessment
Time frame: 16 weeks
Safety and tolerability assessment based on adverse event / serious adverse event (AE / SAE) and adverse device / serious adverse device effects (ADE / SADE) reporting using CTCAE/MedDRA coding terms
Safety endpoints of special interest assessment
Time frame: 16 weeks
Incidence of tumor lysis syndrome and systemic inflammatory response syndrome.
Clinical endpoint - overall survival
Time frame: 16 weeks
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Overall Survival (OS). Overall survival ( OS ) is defined as the time from randomization to death from any cause, is adirect measure of clinical benefit to a patient.
Clinical endpoint - progression free survival
Time frame: 16 weeks
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Progression Free Survival (PFS) Progression-free survival ( pfs ) is defined as time from randomization until firstevidence of tumour progression or until death from any cause, whichever comes first.
Clinical endpoint - disease control rate
Time frame: 16 weeks
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the firststudy treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameterswill be:Disease Control Rate (DCR) Overall response rate (ORR) is defined as the proportion of patients who have a partialor complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.In contrast, disease control rate is a composite of ORR and stable disease and is useful to measure the efficacy oftherapies that have tumoristatic effects rather than tumoricidal effects.
7 secondary outcomes
Nutritional status
Time frame: 16 weeks
Patient functioninig with Eastern Cooperative Oncology Group (ECOG)
Time frame: 16 weeks
Quality-of-life (QoL) Assessment with EQ-5D-5L scale
Time frame: 16 weeks
Quality-of-life (QoL) Assessment with EORTC-QLQ-C30 scale
Time frame: 16 weeks
Quality-of-life (QoL) Assessment with EORTC: QLQ-BR23
Time frame: 16 weeks
Physical performance status assessment with 6 minute walk test (6MWT)
Time frame: 16 weeks
Muscle performance assessment with a hand grip test
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 3
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Advanced Breast Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Ostrowski,MD Medical Director, International - Immunicom, Inc. contact
Robert Segal,MD, FACP Chief Medical Officer - Immunicom, Inc. contact
Adam Ostrowski, MD study director
Immunicom Inc
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy and Chemotherapy Drugs, Cancer in people with Advanced Breast Cancer, run by Immunicom Inc at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Ostrowski,MD Medical Director, International - Immunicom, Inc. (+48 606 446610, adam.ostrowski@immunicom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble Tumor Necrosis Factor Receptor (sTNFR) concentrations in plasma (picogram per mL) (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.