Breast Cancer Clinical Trial

A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patients must meet the following criteria to enroll in this study:

Part 1 Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma
Part 2 Ovarian Cancer or Endometrial Cancer
No other meaningful life-prolonging therapy option available
Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of ELU001 for folate receptor alpha (FRα) expression analysis. Previous FRα expression test results may be used in certain circumstances
Adequate organ function
Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1
Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; Part 2: ECOG performance status of 0 or 1.
Recovered from previous surgeries
Agree to highly effective contraception, not to get pregnant, or for men, not father a child during study participation

Key Exclusion Criteria:

Patients who meet any of the following are not eligible to enroll in this study:

Clinically significant eye disorders
Taken any treatments that use the protein folate receptor alpha or FRα to work
Taken any other experimental treatments
History of significant cardiac issues or other cancers within 3 years.
Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g., not enough platelets in your blood - platelets held stop bleeding in your body)
Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.
If you are pregnant.
Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE (systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress your immune system.
Part 1: if your cancer has spread to your brain.
Part 2: You can have cancer that has spread to your brain but there are exceptions. The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3 cm, there can be no evidence on a scan that shows your brain tissue has shifted from its expected position inside the skull (called "herniation") or be bleeding in the skull or brain itself (called "hemorrhage").

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

166

Study ID:

NCT05001282

Recruitment Status:

Recruiting

Sponsor:

Elucida Oncology

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There are 18 Locations for this study

See Locations Near You

Mayo Clinic - Phoenix, AZ
Phoenix Arizona, 85054, United States
Providence Medical Foundation
Fullerton California, 92835, United States More Info
David J Park, MD
Contact
David J Park, MD
Principal Investigator
Mayo Clinic - Jacksonville, FL
Jacksonville Florida, 32224, United States More Info
Gerardo Colon-Otero, MD
Contact
[email protected]
Colon-Otero Gerardo, M
Principal Investigator
D&H Cancer Research Center
Margate Florida, 33063, United States More Info
David J Kahn, MD
Contact
David J Kahn, MD
Principal Investigator
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando Florida, 32827, United States More Info
Cesar A Perez Batista, MD
Contact
Cesar A Perez Batista, MD
Principal Investigator
Hope and Healing Cancer Services
Hinsdale Illinois, 60521, United States More Info
Srilata Gundala, MD
Contact
Srilata Gundala, MD
Principal Investigator
OSF Saint Francis Medical Center
Peoria Illinois, 61606, United States More Info
Michelle R Rowland, MD, Phd, MPH
Contact
Michelle R Rowland, MD, Phd, MPH
Principal Investigator
Mayo Clinic - Rochester, MN
Rochester Minnesota, 55905, United States More Info
Andrea Wahner-Hendrickson, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Clinical Trials Information
Contact
646-888-4226
Yonina R Murciano-Goroff, MD, MsC
Principal Investigator
Duke University Medical Center - Duke Cancer Institute
Durham North Carolina, 27719, United States More Info
Carey Anders, MD
Contact
Carey Anders, MD
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Wen Wee Ma, MBBS
Contact
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States More Info
Babar Bashir, MD
Contact
Babir Bashir, MD
Principal Investigator
Women & Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States More Info
Cara Mathews, MD
Contact
Cara Mathews, MD
Principal Investigator
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States More Info
Luis Rojas-Espaillat, MD
Contact
Luis Rojas-Espaillat, MD
Principal Investigator
Sarah Cannon Research Institute at Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Erika P Hamilton, MD
Principal Investigator
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Karina Amaro, Study Coord
Contact
[email protected]
Teresa Marquez, ClinTrialMg
Contact
[email protected]
Douglas Orr, MD
Principal Investigator
New Experimental Therapeutics of San Antonio (NEXT Oncology)
San Antonio Texas, 78229, United States More Info
NEXT Coordinators
Contact
210-580-9500
[email protected]
Anthony W Tolcher, MD, FRCPC
Principal Investigator
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Elizabeth Swisher, MD
Contact
Elizabeth Swisher, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

166

Study ID:

NCT05001282

Recruitment Status:

Recruiting

Sponsor:


Elucida Oncology

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