Farletuzumab Ecteribulin for Solid Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called farletuzumab ecteribulin for several types of solid tumors, including certain types of ovarian, endometrial, lung, and breast cancer. The study aims to determine a safe and effective dose and evaluate how well the treatment shrinks tumors. Participants may receive the drug alone or in combination with other medications, and the trial will assess different treatment schedules. Suitable candidates have advanced cancer that hasn't responded well to other treatments, such as chemotherapy, and have experienced disease progression after their last treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking certain medications before starting the trial. There is a required 'washout period' (time without taking certain medications) from the end of your previous treatment to the first administration of the study drug. This period is more than 3 weeks for chemotherapy, surgical therapy, and radiation therapy, 4 weeks for antibody and other biologic agents, 2 weeks for endocrine or small-molecule targeted therapy, and 4 weeks for immunotherapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that farletuzumab ecteribulin, the treatment under study, may help treat solid cancers like ovarian cancer. In one study, doses of 0.9 mg/kg and 1.2 mg/kg were selected for further testing because they proved to be safe and effective. However, one patient experienced a serious lung issue that might be linked to the treatment.
The current trial combines early and later stages, so some safety information is available, but more research is needed to fully understand its safety. Participants should know that while the treatment appears promising, it is still being evaluated for overall safety and tolerability.12345Why are researchers excited about this trial's treatments?
Researchers are excited about farletuzumab ecteribulin, a promising option for treating solid cancers like endometrial and ovarian cancer. Unlike traditional chemotherapy, farletuzumab ecteribulin combines an antibody (farletuzumab) with a cytotoxic agent (ecteribulin), allowing it to specifically target and attack cancer cells while sparing normal, healthy cells. This targeted approach could result in fewer side effects and improved effectiveness compared to existing treatments. Additionally, the potential to enhance results further by combining it with other drugs like lenvatinib or corticosteroids offers a flexible and innovative strategy not commonly seen in standard care.
What evidence suggests that farletuzumab ecteribulin might be an effective treatment for solid cancers?
Research shows that farletuzumab ecteribulin, a treatment in this trial, holds promise, particularly for ovarian cancer. Studies have found it can slow the disease and extend patient survival. This treatment targets a protein called folate receptor alpha (FRα), often abundant on cancer cells. By focusing on this protein, the treatment can deliver chemotherapy directly to the cancer, potentially increasing its effectiveness. In this trial, some participants will receive farletuzumab ecteribulin with lenvatinib, which has shown early signs of combating tumors in patients with hard-to-treat ovarian cancer. Other participants will receive farletuzumab ecteribulin with oral corticosteroids to explore potential improvements in treatment effects, though more information is needed to confirm these benefits.12346
Are You a Good Fit for This Trial?
Adults with certain advanced cancers (ovarian, endometrial, lung adenocarcinoma, or triple-negative breast cancer) who have undergone previous treatments and are not currently pregnant or breastfeeding. Participants must have a life expectancy of at least 3 months, good organ function, and no severe heart issues or active infections. They cannot have brain metastases unless specific conditions are met.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive farletuzumab ecteribulin to evaluate safety, tolerability, and determine the recommended Phase 2 dose
Dose Confirmation
Evaluate preliminary efficacy and further assess safety and tolerability of farletuzumab ecteribulin
Dose Optimization Part A
Evaluate different treatment regimens and use of oral corticosteroids for safety and efficacy
Dose Optimization Part B
Further evaluate selected treatment regimens for safety and efficacy in advanced EC
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Corticosteroid
- Farletuzumab ecteribulin
- MORAb-202
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisai Inc.
Lead Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania