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.
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
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
- 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
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
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- 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)
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- 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
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.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Endometrial Cancer, Ovary Cancer, Ovary Neoplasm
- 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 group | Role | What they receive |
|---|---|---|
| ELU001 | Experimental | Dose 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.
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
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)
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.
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.
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.
- First posted11 Aug 2021
- Study start13 Sep 2021
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Why it stopped: Lack of Funding - no safety issue with Drug; Company Permanently Closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Elucida Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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