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10 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
balixafortide (POL 6326) / Spexis
2018-004211-42: A clinical study to compare treatment of Balixafortide in combination with Eribulin or Eribulin alone, in patients with no protein HER2 present in their cells and had locally repeated or spread breast cancer.

Not yet recruiting
3
384
RoW, Europe
Balixafortide, Halaven, POL6326, Concentrate for solution for infusion, Solution for injection, Halaven
Polyphor Ltd., Polyphor Ltd.
Patients with HER2 negative, Locally Recurrent or Metastatic Breast Cancer, Patients with breast cells that do not have on their surface the HER2 protein (receptor for the Human epidermal growth factor receptor 2) and that have locally repeated or spread breast cancer, Diseases [C] - Cancer [C04]
 
 
FORTRESS, NCT03786094: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Terminated
3
432
Europe, US, RoW
Eribulin, Eribulin Injection [Halaven], Balixafortide, POL6326
Spexis AG
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
10/21
10/21
2008-005046-23: A Phase IIa, Proof of Concept Study to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients with Multiple Myeloma

 
2
36
Europe
POL6326, POL6326,
Polyphor AG
Multiple Myeloma
 
 
POLTER, NCT04826016: POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

Withdrawn
1/2
168
NA
POL6326, Balixafortide, Eribulin, Halaven, Nab paclitaxel, Abraxane
MedSIR
Advanced Breast Cancer
03/22
03/22
NCT06981806: Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma

Not yet recruiting
1
24
US
Balixafortide, Dose Level 1 - Balixafortide 7.5 mg/kg, Dose Level 2 - Balixafortide 11 mg/kg, Cosibelimab, Dose Level 1 - Balixafortide 16 mg/kg
Arsen Osipov
Metastatic Pancreatic Ductal Adenocarcinoma
10/27
10/27
NIR-II, NCT06713161: Tumor-Targeted- Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

Recruiting
N/A
40
RoW
NIR-II Probe(i.e ICG-POL6326) incubation solution
Yunnan Cancer Hospital, Xiang'an Hospital of Xiamen University
Breast Cancer, Sentinel Lymph Node, Metastases, Margin Assessment
08/25
12/25
lonodelestat (POL6014) / Spexis, Cold Spring Harbor Laboratory
2018-002550-71: A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis

Ongoing
1/2
40
Europe
POL6014, Nebuliser solution
Santhera Pharmaceuticals (Switzerland) Ltd, Santhera Pharmaceuticals (Switzerland) Ltd
Cystic fibrosis, mucoviscidosis, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
ColiFin (colistimethate sodium inhalation) / Pari, Spexis
ACTRN12624000601538: Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)

Not yet recruiting
3
38
 
Spexis Australia Pty Ltd, Spexis Australia Pty Ltd
Cystic Fibrosis , Pseudomonas aeruginosa infection
 
 
2022-000476-18: A study to test how well inhalation of Colistimethate Sodium once a day is tolerated and how safe it is compared with inhalation of Colistimethate Sodium two times a day in adult and children with Cystic Fibrosis and lung infection (COPILOT) Ez a vizsgálat annak tesztelésére szolgál, hogy a kolisztimetát-nátrium napi egyszeri belélegzése mennyire tolerálható, és mennyire biztonságos a kolisztimetát-nátrium napi kétszeri belélegzéséhez képest cisztás fibrózisban és tüdőfertőzésben szenvedő felnőtteknél és gyermekeknél (COPILOT)

Ongoing
3
38
Europe
Colistimethate sodium (CMS), Powder for nebuliser solution, Colfinair 2 MIU Powder for Nebuliser Solution
EnBiotix, Inc., EnBiotix, Inc.
Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, Chronic lung infections caused by specific bacteria called Pseudomonas aeruginosa in patients with cystic fibrosis., Diseases [C] - Bacterial Infections and Mycoses [C01]
 
 
2021-002335-33: Inhalation therapy in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial Inhalationstherapie bei erwachsenen Bronchiektase-Patienten mit früher asymptomatischer Pseudomonas aeruginosa-Infektion - eine offene, randomisierte Proof of Concept IIT Studie

Not yet recruiting
2
66
Europe
ColiFin, J01X B01, Powder for nebuliser solution, ColiFin(R)
Philipps University Marburg, German Center for Lung Research (DZL), PARI GmbH
bronchiectasis, permanent enlargement of parts of the airways of the lung (bronchiectasis), with inflammatory processes, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
POL7306 / Spexis
No trials found
SPX5551 / Spexis
No trials found
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
balixafortide (POL 6326) / Spexis
2018-004211-42: A clinical study to compare treatment of Balixafortide in combination with Eribulin or Eribulin alone, in patients with no protein HER2 present in their cells and had locally repeated or spread breast cancer.

Not yet recruiting
3
384
RoW, Europe
Balixafortide, Halaven, POL6326, Concentrate for solution for infusion, Solution for injection, Halaven
Polyphor Ltd., Polyphor Ltd.
Patients with HER2 negative, Locally Recurrent or Metastatic Breast Cancer, Patients with breast cells that do not have on their surface the HER2 protein (receptor for the Human epidermal growth factor receptor 2) and that have locally repeated or spread breast cancer, Diseases [C] - Cancer [C04]
 
 
FORTRESS, NCT03786094: Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Terminated
3
432
Europe, US, RoW
Eribulin, Eribulin Injection [Halaven], Balixafortide, POL6326
Spexis AG
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
10/21
10/21
2008-005046-23: A Phase IIa, Proof of Concept Study to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients with Multiple Myeloma

 
2
36
Europe
POL6326, POL6326,
Polyphor AG
Multiple Myeloma
 
 
POLTER, NCT04826016: POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

Withdrawn
1/2
168
NA
POL6326, Balixafortide, Eribulin, Halaven, Nab paclitaxel, Abraxane
MedSIR
Advanced Breast Cancer
03/22
03/22
NCT06981806: Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma

Not yet recruiting
1
24
US
Balixafortide, Dose Level 1 - Balixafortide 7.5 mg/kg, Dose Level 2 - Balixafortide 11 mg/kg, Cosibelimab, Dose Level 1 - Balixafortide 16 mg/kg
Arsen Osipov
Metastatic Pancreatic Ductal Adenocarcinoma
10/27
10/27
NIR-II, NCT06713161: Tumor-Targeted- Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

Recruiting
N/A
40
RoW
NIR-II Probe(i.e ICG-POL6326) incubation solution
Yunnan Cancer Hospital, Xiang'an Hospital of Xiamen University
Breast Cancer, Sentinel Lymph Node, Metastases, Margin Assessment
08/25
12/25
lonodelestat (POL6014) / Spexis, Cold Spring Harbor Laboratory
2018-002550-71: A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis

Ongoing
1/2
40
Europe
POL6014, Nebuliser solution
Santhera Pharmaceuticals (Switzerland) Ltd, Santhera Pharmaceuticals (Switzerland) Ltd
Cystic fibrosis, mucoviscidosis, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
ColiFin (colistimethate sodium inhalation) / Pari, Spexis
ACTRN12624000601538: Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)

Not yet recruiting
3
38
 
Spexis Australia Pty Ltd, Spexis Australia Pty Ltd
Cystic Fibrosis , Pseudomonas aeruginosa infection
 
 
2022-000476-18: A study to test how well inhalation of Colistimethate Sodium once a day is tolerated and how safe it is compared with inhalation of Colistimethate Sodium two times a day in adult and children with Cystic Fibrosis and lung infection (COPILOT) Ez a vizsgálat annak tesztelésére szolgál, hogy a kolisztimetát-nátrium napi egyszeri belélegzése mennyire tolerálható, és mennyire biztonságos a kolisztimetát-nátrium napi kétszeri belélegzéséhez képest cisztás fibrózisban és tüdőfertőzésben szenvedő felnőtteknél és gyermekeknél (COPILOT)

Ongoing
3
38
Europe
Colistimethate sodium (CMS), Powder for nebuliser solution, Colfinair 2 MIU Powder for Nebuliser Solution
EnBiotix, Inc., EnBiotix, Inc.
Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, Chronic lung infections caused by specific bacteria called Pseudomonas aeruginosa in patients with cystic fibrosis., Diseases [C] - Bacterial Infections and Mycoses [C01]
 
 
2021-002335-33: Inhalation therapy in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial Inhalationstherapie bei erwachsenen Bronchiektase-Patienten mit früher asymptomatischer Pseudomonas aeruginosa-Infektion - eine offene, randomisierte Proof of Concept IIT Studie

Not yet recruiting
2
66
Europe
ColiFin, J01X B01, Powder for nebuliser solution, ColiFin(R)
Philipps University Marburg, German Center for Lung Research (DZL), PARI GmbH
bronchiectasis, permanent enlargement of parts of the airways of the lung (bronchiectasis), with inflammatory processes, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
POL7306 / Spexis
No trials found
SPX5551 / Spexis
No trials found

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