Clinical Trials

Date: 2016-10-10

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress

Company: Endocyte (USA - IN)

Product: EC1456

Action mechanism:

EC1456 is an investigational therapeutic small molecule drug conjugate (SMDC) constructed of folic acid conjugated through a spacer and releasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. The high affinity of the folic acid ligand for the FR allows for the active and specific targeting of EC1456 to FR-expressing cancer cells. The FR is highly expressed in several epithelial cancers (e.g. ovarian, NSCLC) but is expressed at low levels in most normal tissues.
Etarfolatide is an FR-targeted companion imaging agent being co-developed to characterize whole body FR expression in real time, to identify patients most likely to benefit from EC1456 therapy.

Disease: non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• On October 10, 2016, Endocyte presented poster update on its EC1456 clinical programs at the European Society for Medical Oncology (ESMO) 2016 Congress, being held in Copenhagen, DenmarkOctober 7-11, 2016.
EC1456 Poster #395P - Dose Escalation Phase 1, Safety and Pharmacokinetic Study of the Folate Receptor-Targeted Drug Conjugate EC1456 in Advanced Cancer Patients: Study Update
A dose of 6.0 mg/m2 was established as the maximum twice per week dose, administered 2 weeks out of a 3 week cycle, which is being used in the expansion phase of the trial in FR-positive NSCLC patients. EC1456 was well tolerated, with primary toxicities including fatigue, GI toxicity, and electrolyte disturbance; predominantly grade 1 and 2, reversible and responsive to simple medication. In spite of the inclusion of patients who were not selected as positive for the targeted FR, most patients demonstrated stable disease as best response and several patients demonstrated a reduction in target tumor volume.