Topoisomerase I inhibitors
ELU001 for Breast Cancer
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
No other meaningful life-prolonging therapy option available
No other meaningful life-prolonging therapy option available
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfirst dose of study drug until responses of cr or pr, assessed up to 12 months.
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Breast Cancer
- Gastric Cancer
- Esophageal Cancer
- Bile Duct Cancer
- Ovarian Tumors
- Ovarian Disease
- Endometriosis
- Cholangiocarcinoma
- Intrahepatic Cholangiocarcinoma
- Rectal Cancer
- Ovarian Metastasis
- Endometrial Cancer
- Ovarian Cancer
- Stomach Cancer
- Colon Cancer
- Colorectal Cancer
- Liver Metastasis
- Endometrial Adenocarcinoma
- Endometrial Carcinosarcoma
- Endometrioid Adenocarcinoma
- Endometrioid Tumor
- Peritoneal Neoplasm
- Gastroesophageal Junction Adenocarcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
There are no other treatment options available that can significantly extend your life.
Select...
There are no other effective treatments available to prolong your life.
Select...
You have fully healed from any past surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose of study drug until responses of cr or pr, assessed up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose of study drug until responses of cr or pr, assessed up to 12 months.
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 site
Who is running the clinical trial?
Elucida OncologyLead Sponsor
2 Previous Clinical Trials
31 Total Patients Enrolled
Eliel Bayever, MBBCh, MRCPStudy Director
Elucida Oncology, Inc.Media Library
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
Thomas Jefferson University, Sidney Kimmel Cancer Center
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.
Patient
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.
Patient