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Topoisomerase I inhibitors

ELU001 for Ovarian and Endometrial Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Elucida Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose of study drug until responses of cr or pr, assessed up to 12 months.
Awards & highlights

Study Summary

This trial is focused on subjects with advanced, recurrent or refractory FRα overexpressing tumors. ELU001 is a new chemical entity consisting of payloads and targeting moieties covalently bound by linkers to the C'Dot particle carrier. This is the first trial of its kind and a novel molecular entity.

Who is the study for?
Adults with advanced, recurrent or refractory tumors that have high levels of a protein called folate receptor alpha (FRα) and are sensitive to certain chemotherapy drugs. Participants must be in fairly good health, not pregnant or planning to become so, have recovered from any surgeries, and lack other treatment options.Check my eligibility
What is being tested?
ELU001 is being tested; it's a new type of drug-conjugate designed to target cancer cells overexpressing FRα. It combines a chemotherapy agent with folic acid analogs linked to a carrier particle, aiming for precise delivery to the tumor while sparing healthy tissue.See study design
What are the potential side effects?
Specific side effects of ELU001 aren't detailed here but may include typical reactions related to chemotherapy such as fatigue, nausea, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer can be measured by standard tests or, if not, it still follows certain criteria.
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I have no other treatment options that could significantly extend my life.
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I have no other treatment options that could significantly extend my life.
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My cancer can be measured by standard tests or, if not, it still meets certain criteria.
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My organs are working well.
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My cancer can be measured by standard criteria or, if not, it still follows specific guidelines.
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I have no other treatment options that could significantly extend my life.
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I have no other treatment options that could significantly extend my life.
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I can provide a sample of my tumor for testing before starting ELU001 treatment.
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I have been diagnosed with a specific type of cancer listed.
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I have fully recovered from my past surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose of study drug until responses of cr or pr, assessed up to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose of study drug until responses of cr or pr, assessed up to 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
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.
Secondary outcome measures
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.
Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ELU001Experimental Treatment1 Intervention
Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)

Find a Location

Who is running the clinical trial?

Elucida OncologyLead Sponsor
2 Previous Clinical Trials
10 Total Patients Enrolled
Eliel Bayever, MBBCh, MRCPStudy DirectorElucida Oncology, Inc.

Media Library

ELU001 (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT05001282 — Phase 1 & 2
Ovarian Tumors Research Study Groups: ELU001
Ovarian Tumors Clinical Trial 2023: ELU001 Highlights & Side Effects. Trial Name: NCT05001282 — Phase 1 & 2
ELU001 (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05001282 — Phase 1 & 2
Ovarian Tumors Patient Testimony for trial: Trial Name: NCT05001282 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical clinics is this medical study being run today?

"You can find this trial at 9 locations across America, with sites in New york, Durham, and Nashville. If you want to minimize travel, it would be best to select the centre closest to your home."

Answered by AI

How many individuals are allowed to enroll in this clinical trial?

"That is correct. The information available on clinicaltrials.gov affirms that this study, which was originally advertised on September 13th 2021, is still recruiting patients. A total of 166 people are needed for the trial taking place at 9 hospitals or clinics."

Answered by AI

Are we still enrolling people for this experiment?

"The information on clinicaltrials.gov indicates that this study is still recruiting patients. The trial was originally posted on September 13th, 2021 and was last updated on August 18th, 2022. The study is looking for 166 patients across 9 sites."

Answered by AI

Who else is applying?

What state do they live in?
New York
Arizona
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
Mayo Clinic - Phoenix, AZ
Mayo Clinic - Jacksonville, FL
Duke University Medical Center - Duke Cancer Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I did 5 rounds taxol/carbo and 1 round Carbo. Partial response and had debulking surgery. Was supposed to start parp and maybe avastin. Did two more rounds of Carbo. Some progression so Oncologist has started me on Avastin/Doxil.
PatientReceived 1 prior treatment
I was on chemotherapy and did the full treatment cycle, was put on immunotherapy for ever 6 weeks with zometa for lytic lesions. My most recent PET scan came back and the results show that the cancer has progressed and I want to try this clinical trial to see if it can help as my oncologist wants to put me back on cis/gen.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

~10 spots leftby Jun 2024