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

March 27, 2024 updated by: Elucida Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

166

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Withdrawn
        • Mayo Clinic - Phoenix, AZ
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • David J Park, MD
        • Contact:
          • David J Park, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville, Fl
        • Contact:
        • Principal Investigator:
          • Colon-Otero Gerardo, M
      • Margate, Florida, United States, 33063
        • Not yet recruiting
        • D&H Cancer Research Center
        • Contact:
          • David J Kahn, MD
        • Principal Investigator:
          • David J Kahn, MD
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute at Florida Cancer Specialists
        • Principal Investigator:
          • Cesar A Perez Batista, MD
        • Contact:
          • Cesar A Perez Batista, MD
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope and Healing Cancer Services
        • Principal Investigator:
          • Srilata Gundala, MD
        • Contact:
          • Srilata Gundala, MD
      • Peoria, Illinois, United States, 61606
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
          • Michelle R Rowland, MD, Phd, MPH
        • Principal Investigator:
          • Michelle R Rowland, MD, Phd, MPH
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester, Mn
        • Principal Investigator:
          • Andrea Wahner-Hendrickson, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Clinical Trials Information
          • Phone Number: 646-888-4226
        • Principal Investigator:
          • Yonina R Murciano-Goroff, MD, MsC
    • North Carolina
      • Durham, North Carolina, United States, 27719
        • Recruiting
        • Duke University Medical Center - Duke Cancer Institute
        • Principal Investigator:
          • Carey Anders, MD
        • Contact:
          • Carey Anders, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Wen Wee Ma, MBBS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University, Sidney Kimmel Cancer Center
        • Contact:
          • Babar Bashir, MD
        • Principal Investigator:
          • Babir Bashir, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital of Rhode Island
        • Principal Investigator:
          • Cara Mathews, MD
        • Contact:
          • Cara Mathews, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
          • Luis Rojas-Espaillat, MD
        • Principal Investigator:
          • Luis Rojas-Espaillat, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute at Tennessee Oncology
        • Principal Investigator:
          • Erika P Hamilton, MD
    • Texas
      • Dallas, Texas, United States, 75230
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • New Experimental Therapeutics of San Antonio (NEXT Oncology)
        • Contact:
        • Principal Investigator:
          • Anthony W Tolcher, MD, FRCPC
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Elizabeth Swisher, MD
        • Principal Investigator:
          • Elizabeth Swisher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELU001
Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)
Drug: ELU001
Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)
Other Names:
  • FA-CDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 Dose Escalation: The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.
Time Frame: 28 days
To determine the MTD and/or RP2D of ELU001 in patients with over-expressing Folate Receptor Alpha tumors. When at least 2 out of 6 patients in a given dose-level experience a dose-limiting toxicity (DLT), the dose is considered to have exceeded the MTD. The MTD, therefore, is defined as the previous highest tested dose of ELU001 that did not cause a DLT in the first cycle of treatment. In the event of emerging data during Part 1, the Sponsor may, in consultation with a dose-level safety review group, decide to define a recommended dose for expansion (in for Part 2) (RP2D) instead of the MTD. DLTs are defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to ELU001 treatment that result in a failure to meet the criteria for re-treatment.
28 days
Part 2 Dose Expansion: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.
Time Frame: First dose of study drug until responses of CR or PR, assessed up to 12 months.
Percentage of Participants with confirmed objective response as assessed by the investigator and per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR is defined as the disappearance of all target or non-target lesions. PR is defined as at least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
First dose of study drug until responses of CR or PR, assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 Dose Escalation: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.
Time Frame: First dose of study drug until responses of CR or PR, assessed up to 12 months.
Percentage of Participants with confirmed objective response as assessed by the investigator and per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR is defined as the disappearance of all target or non-target lesions. PR is defined as at least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
First dose of study drug until responses of CR or PR, assessed up to 12 months.
Part 1 and Part 2: To determine Duration of Response (DOR) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.
Time Frame: Date of first response (CR or PR) until the date of disease progression or up to 12 months, whichever occurs first.
Time Measurement: DOR will begin at the date that a response has been identified (stable disease, partial response, or complete response) until the date of progressive disease (PD). PD is defined of at least a 20% increase in the sum of the longest diameters of the target lesions from data of initial response.
Date of first response (CR or PR) until the date of disease progression or up to 12 months, whichever occurs first.
Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.
Time Frame: First dose of study drug up to 28 days after the last dose of study drug or up to 12 months, whichever occurs first.
The number of participants Frequency/severity of abnormalities in vital signs measurements, physical examination findings, changes in clinical laboratory parameters, and incidence of adverse events after taking ELU001.
First dose of study drug up to 28 days after the last dose of study drug or up to 12 months, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elucida Oncology

Investigators

  • Study Director: Eliel Bayever, MBBCh, MRCP, Elucida Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELU-FRα-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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