This study, ELU- FRα-1, was 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05001282.
The study had 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 closed for recruitment.
Lead OrganizationElucida Oncology