NCT01065025: AEGIS

Open Label, Dose Escalation Trial of Oral 4SC-205 in Patients With Advanced Malignancies: First-In-Man Study of a Newly Developed, Oral Inhibitor of Kinesin-spindle Protein, Eg5

Completed Phase 1 Last updated 10 April 2015

What this trial tests

Phase 1 trial testing 4SC-205 in Advanced and Incurable Solid Tumors in 60 participants. Completed in 1 April 2015.

Timeline

1 January 2010

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	4SC AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2010
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	2 locations across Germany

Drugs / interventions tested

• 4SC-205 — full drug profile →

Conditions studied

• Advanced and Incurable Solid Tumors — all drugs for Advanced and Incurable Solid Tumors →
• Malignant Lymphomas — all drugs for Malignant Lymphomas →

Sponsor

4SC AG — full company profile →

Who can join

18 and older, any sex, with Advanced and Incurable Solid Tumors or Malignant Lymphomas. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and tolerability of repeated ascending oral doses of 4SC-205. Determination of the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT).
  Time frame: 6 weeks

Sponsor's own description

The purpose of the study is to investigate safety and tolerability of repeated ascending oral doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.

Publications & conference data

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

1. Cytotoxicity of paclitaxel in breast cancer is due to chromosome missegregation on multipolar spindles.
   Zasadil LM, Andersen KA, Yeum D, Rocque GB, et al · · 2014 · cited 321× · PMID 24670687 · DOI 10.1126/scitranslmed.3007965
2. The two sides of chromosomal instability: drivers and brakes in cancer.
   Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
3. Second-Generation Antimitotics in Cancer Clinical Trials.
   Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
4. Eg5 inhibitor YL001 induces mitotic arrest and inhibits tumor proliferation.
   Wang Y, Wu X, Du M, Chen X, et al · · 2017 · cited 14× · PMID 28489567 · DOI 10.18632/oncotarget.17207
5. Mitosis phase enrichment with identification of mitotic centromere-associated kinesin as a therapeutic target in castration-resistant prostate cancer.
   Sircar K, Huang H, Hu L, Liu Y, et al · · 2012 · cited 13× · PMID 22363599 · DOI 10.1371/journal.pone.0031259
6. The oral KIF11 inhibitor 4SC-205 exhibits antitumor activity and potentiates standard and targeted therapies in primary and metastatic neuroblastoma models.
   Masanas M, Masiá N, Suárez-Cabrera L, Olivan M, et al · · 2021 · cited 9× · PMID 34709738 · DOI 10.1002/ctm2.533
7. Mitotic Machinery Dysregulation in Lung Cancer: Biological Roles, Therapeutic Targeting, and Combination Strategies.
   Pinto B, Silva JPN, Silva PMA, Sarmento B, et al · · 2026 · PMID 42076055 · DOI 10.3390/pharmaceutics18040402
8. Kinesin Spindle Protein (KIF11) in Mitosis and Cancer.
   Silva JPN, Silva PMA, Bousbaa H. · · 2025 · PMID 41009541 · DOI 10.3390/ijms26188975