Balixafortide

Generic Name: Balixafortide

Drug Type: Biotech

CAS Number: 1051366-32-5

Unique Ingredient Identifier: PRC974M49B

Background: Balixafortide is under investigation in clinical trial NCT03786094 (Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer).

Clinical Trials

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1

Not yet recruiting

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Balixafortide
Drug: Cosibelimab

First Posted Date: 2025-05-21

Last Posted Date: 2025-05-21

Lead Sponsor: Arsen Osipov

Target Recruit Count: 24

Registration Number: NCT06981806

Locations: 🇺🇸
Cedars-Sinai Cancer at SOCC, Los Angeles, California, United States

POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

Phase 1

Withdrawn

Conditions: Advanced Breast Cancer

Interventions: Drug: POL6326
Drug: Nab paclitaxel
Drug: Eribulin

First Posted Date: 2021-04-01

Last Posted Date: 2023-03-20

Lead Sponsor: MedSIR

Registration Number: NCT04826016

Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

Phase 3

Terminated

Conditions: Metastatic Breast Cancer
Locally Recurrent Breast Cancer

Interventions: Drug: Eribulin
Drug: Balixafortide

First Posted Date: 2018-12-24

Last Posted Date: 2023-11-01

Lead Sponsor: Spexis AG

Target Recruit Count: 432

Registration Number: NCT03786094

Locations: 🇺🇸
California Cancer Associates for Research and Excellence, Fresno, California, United States
🇺🇸
Tallahassee Memorial HealthCare, Tallahassee, Florida, United States
🇺🇸
West Virginia University Hospital, Morgantown, West Virginia, United States

and more 85 locations

CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)

Phase 2

Completed

Conditions: Large Reperfused ST-Elevation Myocardial Infarction

Interventions: Drug: Placebo
Drug: POL6326

First Posted Date: 2013-07-23

Last Posted Date: 2016-06-10

Lead Sponsor: Polyphor Ltd.

Target Recruit Count: 120

Registration Number: NCT01905475

Locations: 🇭🇺
Magyar Honvédség Egészségügyi Központ, Kardiológiai osztály, Budapest, Hungary
🇭🇺
DEOEC, Kardiológiai Intézet, Debrecen, Hungary
🇬🇧
Edinburgh Heart Centre Royal Infirmary, Edinburgh, United Kingdom

and more 14 locations

Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: POL6326

First Posted Date: 2013-04-26

Last Posted Date: 2015-11-25

Lead Sponsor: Polyphor Ltd.

Target Recruit Count: 27

Registration Number: NCT01841476

Locations: 🇩🇪
German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany

Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: POL6326

First Posted Date: 2013-04-22

Last Posted Date: 2018-09-14

Lead Sponsor: Polyphor Ltd.

Target Recruit Count: 54

Registration Number: NCT01837095

Locations: 🇺🇸
Washington University School of Medicine, Division of Oncology, Saint Louis, Missouri, United States
🇺🇸
Vanderbilt University School of Medicine, Nashville, Tennessee, United States
🇪🇸
HGUG Marañón, Madrid, Spain

and more 9 locations

Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies

Phase 1

Completed

Conditions: Acute Myeloid Leukemia in Remission
Adult Acute Lymphoblastic Leukemia in Remission
Chronic Myelogenous Leukemia (CML)
Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease (HD) in 2nd or Greater Complete Remission, Partial Remission
Chronic Lymphocytic Leukemia (CLL)
Multiple Myeloma (MM)
Myelodysplastic Syndrome (MDS)
Myeloproliferative Disorders

Interventions: Drug: POL6326
Procedure: PBSC Transplant
Procedure: Leukapheresis

First Posted Date: 2011-08-10

Last Posted Date: 2016-02-26

Lead Sponsor: Polyphor Ltd.

Target Recruit Count: 38

Registration Number: NCT01413568

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States
🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

Exploratory Study on POL6326 in Stem Cell Mobilization

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: POL6326

First Posted Date: 2010-04-16

Last Posted Date: 2014-04-23

Lead Sponsor: Polyphor Ltd.

Target Recruit Count: 21

Registration Number: NCT01105403

Locations: 🇩🇪
Department of Internal Medicine V, Heidelberg, Germany

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy