NCT04826016 (POLTER) is a Phase 1, PHASE2 clinical trial of POL6326 in Advanced Breast Cancer, sponsored by MedSIR.

Who is sponsoring NCT04826016?

NCT04826016 is sponsored by MedSIR.

What drugs are being tested in NCT04826016?

Interventions in NCT04826016: POL6326, Eribulin, Nab paclitaxel.

What condition does NCT04826016 study?

NCT04826016 studies Advanced Breast Cancer.

Is NCT04826016 still recruiting?

NCT04826016 is currently withdrawn. Last updated 20 March 2023.

Last reviewed 2023-03-20 · How we verify

NCT04826016: POLTER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 1, PHASE2 Last updated 20 March 2023

What this trial tests

Phase 1, PHASE2 trial testing POL6326 in Advanced Breast Cancer. Withdrawn.

Timeline

16 March 2022

Primary endpoint
16 March 2022

16 March 2022

Quick facts

Lead sponsor	MedSIR
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	16 March 2022
Primary completion	16 March 2022
Estimated completion	16 March 2022

Drugs / interventions tested

POL6326 — full drug profile →
Eribulin (ERIBULIN) — full drug profile →
Nab paclitaxel

Conditions studied

Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

MedSIR — full company profile →

Who can join

18 and older, female only, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter Phase Ib/II, open-label, dose-escalation study to optimize POL6326 (balixafortide) in combination with nab-paclitaxel or eribulin in patients with HER2-negative advanced breast cancer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Macrophages Are a Double-Edged Sword: Molecular Crosstalk between Tumor-Associated Macrophages and Cancer Stem Cells.
Luo S, Yang G, Ye P, Cao N, et al · · 2022 · cited 38× · PMID 35740975 · DOI 10.3390/biom12060850
Targeting Cellular Components of the Tumor Microenvironment in Solid Malignancies.
Belli C, Antonarelli G, Repetto M, Boscolo Bielo L, et al · · 2022 · cited 18× · PMID 36077813 · DOI 10.3390/cancers14174278

Verify or expand the search:

Other recruiting trials for Advanced Breast Cancer

Currently open trials in the same condition.

NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07259226 — Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers · Phase 2 · recruiting
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
NCT07428655 — Acceptability and Feasibility of PSC Model of Serious Illness Communication · NA · active not recruiting

Other MedSIR trials

Trials by the same sponsor.

NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04826016 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedSIR
Last refreshed: 20 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04826016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing