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Ovarian CancerPhase 1/2NCT05001282

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

A Phase 1/2 study testing ELU001 in people with Ovarian Cancer and Ovarian Neoplasms, run by Elucida Oncology at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELU001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
18 sitesUnited States
Study dates
13 Sep 2021to 7 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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").

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Duke University Medical Center - Duke Cancer Institute

    Durham, North Carolina, 27719

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

  • Mayo Clinic - Jacksonville, FL

    Jacksonville, Florida, 32224

  • D&H Cancer Research Center

    Margate, Florida, 33063

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61606

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic - Phoenix, AZ

    Phoenix, Arizona, 85054

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Mayo Clinic - Rochester, MN

    Rochester, Minnesota, 55905

  • New Experimental Therapeutics of San Antonio (NEXT Oncology)

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

Other trials in United States

About this study

Official title: 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, 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.

Read the 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.

Being tested
ELU001
Keywords
Folate Receptor Alpha, Carcinomas, Recurrent, Refractory, Folate Receptor alpha moderate expression, Folate Receptor alpha high expression, ELU001, Exatecan, C'Dot, C-Dot, Folic Acid, Payload, Nanoparticle, C'Dot drug conjugate, CDC, Linker, ELU-FRa-1, FOLR1
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Ovarian Diseases, Krukenberg Tumor, Carcinoma, Ovarian Epithelial, Uterine Diseases, Carcinoma, Endometrioid, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELU001Drug

    Also called FA-CDC

    Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)

Study groups in NCT05001282
Study groupRoleWhat they receive
ELU001ExperimentalDose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)
Receives: Drug: ELU001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 28 days

  2. 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.

    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.

    Measured: First dose of study drug until responses of CR or PR, assessed up to 12 months.

Secondary outcomes (3)

  1. 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.

    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.

    Measured: First dose of study drug until responses of CR or PR, assessed up to 12 months.

  2. 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 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.

    Measured: Date of first response (CR or PR) until the date of disease progression or up to 12 months, whichever occurs first.

  3. Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.

    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.

    Measured: First dose of study drug up to 28 days after the last dose of study drug or up to 12 months, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start13 Sep 2021
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

Why it stopped: Lack of Funding - no safety issue with Drug; Company Permanently Closed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Dose Escalation Dose Expansion, Simon's 2-stage
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001282
Sponsor's protocol ID
ELU-FRα-1
Status last verified
Aug 2024
First submitted
14 Jul 2021
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ELU001 in people with Ovarian Cancer and Ovarian Neoplasms, run by Elucida Oncology at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Funding - no safety issue with Drug; Company Permanently Closed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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