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Clinical Trial Summary

This study, ELU- FRα-1, is focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available. ELU001 is a new chemical entity described as a C'Dot drug conjugate (CDC), consisting of payloads (exatecans) and targeting moieties (folic acid analogs) covalently bound by linkers to the C'Dot particle carrier. ELU001 will be the first drug-conjugate of its kind to be introduced into the clinic, a first in class, and a novel molecular entity.


Clinical Trial Description

The study has two parts: Part 1 Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and Part 2 Tumor Group Expansion Cohort(s) where specific cancer types will be evaluated for efficacy and safety at the RP2D. Part 1, subjects with cancer types with a high likelihood of having FRα overexpressing tumors based on historical data, specifically, ovarian, endometrial, colorectal, gastric, gastroesophageal junction, triple negative breast, or non-small cell lung cancers, or cholangiocarcinoma, will be enrolled in a basket clinical study. Retrospective analysis of folate receptor alpha (FRα) expression status will be determined. Part 1 is currently closed for further recruitment. Part 2 Stage 1 of a Simon's Two-Stage design, tumor group expansion cohorts, each consisting of subjects with cancer types studied as part of the basket in Part 1. Part 2 is open for recruitment. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma, Endometrioid
  • Carcinoma, Ovarian Epithelial
  • Carcinosarcoma
  • Endometrial Adenocarcinoma
  • Endometrial Cancer
  • Endometrial Cancer Recurrent
  • Endometrial Carcinosarcoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Diseases
  • Endometrial Neoplasms
  • Endometrioid Adenocarcinoma
  • Fallopian Tube Cancer
  • Fallopian Tube Neoplasms
  • Neoplasms
  • Ovarian Adenocarcinoma
  • Ovarian Cancer
  • Ovarian Cancer Recurrent
  • Ovarian Cancer Stage
  • Ovarian Carcinoma
  • Ovarian Diseases
  • Ovarian Epithelial Cancer
  • Ovarian Neoplasm Epithelial
  • Ovarian Neoplasms
  • Ovarian Serous Adenocarcinoma
  • Ovary Cancer
  • Ovary Disease
  • Ovary Neoplasm
  • Peritoneal Cancer
  • Recurrence
  • Uterine Diseases

NCT number NCT05001282
Study type Interventional
Source Elucida Oncology
Contact Clinical Trial Operations
Phone 732-823-1182
Email clinicaltrialinfo@elucidaoncology.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 13, 2021
Completion date June 15, 2025

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