Trials / Terminated
TerminatedNCT05001282
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Elucida Oncology · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Ovarian Cancer
- Ovarian Neoplasms
- Ovarian Carcinoma
- Endometrial Cancer
- Ovary Cancer
- Ovary Neoplasm
- Ovary Disease
- Ovary Metastasis
- Ovarian Diseases
- Ovarian Cancer Stage
- Ovarian Epithelial Cancer
- Ovarian Adenocarcinoma
- Ovarian Serous Adenocarcinoma
- Ovarian Neoplasm Epithelial
- Ovarian Cancer Recurrent
- Endometrial Diseases
- Endometrial Adenocarcinoma
- Endometrial Carcinosarcoma
- Endometrial Clear Cell Adenocarcinoma
- Endometrioid Adenocarcinoma
- Endometrial Neoplasms
- Endometrial Cancer Recurrent
- Endometrioid Tumor
- Fallopian Tube Cancer
- Peritoneal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELU001 | Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC) |
Timeline
- Start date
- 2021-09-13
- Primary completion
- 2024-06-07
- Completion
- 2024-06-07
- First posted
- 2021-08-11
- Last updated
- 2024-08-07
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05001282. Inclusion in this directory is not an endorsement.