ELU001 for Ovary Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic - Rochester, MN, Rochester, MN
Ovary Cancer+82 More
ELU001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new drug called ELU001 can be used to treat cancer.

See full description

Eligible Conditions

  • Ovary Cancer
  • Colorectal Carcinoma (CRC)
  • Liver Metastasis Colon Cancer
  • Rectal Cancer Metastatic
  • Colon Cancer, Rectal Cancer
  • Ovary Metastasis
  • Ovarian Carcinoma
  • Endometrial Cancer
  • Malignant Neoplasm of Stomach
  • Adenocarcinomas of the Gastroesophageal Junction
  • Adenocarcinoma of the Stomach
  • Colorectal Cancer
  • Cholangiocarcinoma
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Colorectal Adenocarcinoma (CRC)
  • Metastatic Colorectal Cancer (CRC)
  • Stage IV Colorectal Cancer
  • Rectum Cancer
  • Rectum Neoplasms
  • Cancer of Rectum
  • Rectum Carcinoma
  • Rectal Carcinoma
  • Rectal Adenocarcinoma
  • Rectal Cancer Stage
  • Cancer of Esophagus
  • Rectal Cancer (Stage III)
  • Oesophagus Cancer
  • Esophageal Neoplasms Malignant
  • Gastric Cancer Stage
  • Breast Cancer
  • Neoplasms, Breast
  • Breast Adenocarcinoma
  • Triple Negative Breast Neoplasms
  • Carcinoma Breast Stage IV
  • Stage, Breast Cancer
  • Breast Cancer Metastatic
  • Intrahepatic Cholangiocarcinoma
  • Recurrent Intrahepatic Cholangiocarcinoma
  • Hilar Cholangiocarcinoma
  • Ovarian Cancer
  • Distal Cholangiocarcinoma
  • Ovary Neoplasms
  • Ovary Disease
  • Ovarian Cancer Stage
  • Ovarian Cancer (Epithelial)
  • Adenocarcinoma of the Ovaries
  • Ovarian Serous Adenocarcinoma
  • Recurrent Ovarian Cancer
  • Endometrial Diseases
  • Endometrial Adenocarcinomas
  • Endometrial Carcinosarcoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Neoplasms
  • Endometrioid Tumor
  • Fallopian Tubes Cancer
  • Malignant Peritoneal Neoplasm
  • Colon Neoplasms
  • Colon Adenocarcinoma
  • Ovarian Diseases
  • Ovarian Neoplasm Epithelial
  • Bile Duct Carcinoma
  • Malignant Neoplasm of Colon
  • Endometrioid Adenocarcinoma
  • Endometrial Cancer Recurrent
  • Stage, Colon Cancer
  • Invasive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ovary Cancer

Study Objectives

This trial is evaluating whether ELU001 will improve 2 primary outcomes and 3 secondary outcomes in patients with Ovary Cancer. Measurement will happen over the course of 28 days.

28 days
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.
Month 12
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.
Month 12
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 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.
Month 12
Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.

Trial Safety

Safety Progress

1 of 3

Other trials for Ovary Cancer

Trial Design

1 Treatment Group

ELU001
1 of 1
Experimental Treatment

This trial requires 166 total participants across 1 different treatment group

This trial involves a single treatment. ELU001 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

ELU001
Drug
Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose of study drug until responses of cr or pr, assessed up to 12 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly first dose of study drug until responses of cr or pr, assessed up to 12 months. for reporting.

Closest Location

Mayo Clinic - Rochester, MN - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Ovary Cancer or one of the other 82 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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
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

Patient Q&A Section

What is cholangiocarcinoma?

"Contrary to its dismal prognosis, CCA is a very rare cancer. The incidence of CCA seems to be increasing in recent years, but the cause of this increase is unknown. Patients with extrahepatic bile duct cancers should undergo surgical resection as soon as possible so that they can be cured of this deadly disease. In patients who do not respond to surgical resection, intraoperative frozen section analysis may help predict tumor recurrence." - Anonymous Online Contributor

Unverified Answer

How many people get cholangiocarcinoma a year in the United States?

"Cholangiocarcinoma incidence rates are increasing in the United States. This increase is driven largely by an increase in high-risk patients (women, persons older than 65 years, black persons) and increased resection rates for CCA." - Anonymous Online Contributor

Unverified Answer

How serious can cholangiocarcinoma be?

"Cholangiocarcinoma is not rare, and its prognosis is poor. Nevertheless, there were no differences between patients who had cholangiocarcinoma and those who did not. The survival rate after curative resection was similar in both groups. Thus, curative resection should be performed when possible regardless of whether the cancer is benign or malignant." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cholangiocarcinoma?

"The majority of bile duct malignancies were associated with chronic liver diseases (especially HCV infection and alcoholic liver disease), but not with traditional risk factors. Bile duct cancer may have multiple etiologies and is likely underdiagnosed because of its nonspecific clinical presentation." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for cholangiocarcinoma?

"Survival was significantly better for patients with CCA than for those with adenocarcinoma when all variables and tumor characteristics were taken into account. The best survival was for patients with CCA resected surgically (surgery alone or combined with adjuvant chemoradiotherapy) while patients with CCA derived from the perihilar region had an even better prognosis. Survival was worse for patients with CCA arising from the liver, pancreas, gall bladder, or lymph node metastasis who could not have their primary tumor resected surgically. Patients who received neoadjuvant chemotherapy before surgery showed a better survival than those who received postoperative chemotherapy, whereas combination therapy did not show any benefit over monotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving elu001?

"The patient enrolled In a recent study received elu001 at a dose of 1 mg/kg every 3 weeks for 24 weeks. Serious adverse events were observed in patients treated with elu001. All patients were hospitalized and a significant number of patients required elimination from the study. Physicians need to be aware of these serious side effects when using elu001." - Anonymous Online Contributor

Unverified Answer

Is elu001 safe for people?

"The incidence of severe reactions was similar to that reported previously. In contrast, there was no evidence of increased risk of hepatic toxicity or neurological toxicity compared with historical controls. Elucidation of the mechanism(s) responsible for the adverse reactions observed has not been established. However, available data do not support a major role for elu001 as a causative agent for these reactions." - Anonymous Online Contributor

Unverified Answer

Has elu001 proven to be more effective than a placebo?

"The combination of elu001 and a standard chemotherapy regimen may offer better results in advanced CCA. Elu001 may be useful in the therapy of some patients with unresectable CCA. Further studies should assess the efficacy of elu001 as a monotherapy before it is used as part of a combination regimen." - Anonymous Online Contributor

Unverified Answer

Does cholangiocarcinoma run in families?

"Findings from a recent study showed a strong association between multiple endocrine neoplasia type 1 alleles and CC in the Chinese population, supporting the role of hereditary factors in CC genesis." - Anonymous Online Contributor

Unverified Answer

What is elu001?

"Elu001 is a new type of MRI contrast agent without any known side effects for hepatic imaging. Results from a recent paper suggest that elu001 may be useful in distinguishing benign from malignant liver lesions, especially for patients with equivocal or indeterminate liver masses on the basis of conventional MRI." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cholangiocarcinoma?

"The risk of developing cholangiocarcinoma increases with age, particularly after age 60. In addition to surgical resection, the use of endoscopic ultrasound (EUS) to staging the tumor may allow improved detection of early tumors and should be considered when investigating the presence of biliary strictures. The detection rate of intrahepatic cholangiocarcinoma was significantly higher in EUS-based compared to ERCP-based staging, and EUS showed better performance in detecting lymph node involvement and distant metastasis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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