Farletuzumab Ecteribulin for Solid Cancers

Recruiting at 38 trial locations

Overseen By Eisai Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eisai Inc.

Must not be taking: Folate receptor agents

Disqualifiers: Brain metastases, Cardiovascular impairment, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

182 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

Participants at risk for DVT must have venous Doppler ultrasonography

Participants must have available tumor tissue for FRA expression percent (%) by IHC analysis

Participant must be willing and able to comply with all aspects of the protocol

Exclusion Criteria

Participants with Pulmonary Function Test (PFT) abnormalities

I am not taking any medications that are not allowed with the study treatment.

I have brain metastases but meet specific criteria for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive farletuzumab ecteribulin to evaluate safety, tolerability, and determine the recommended Phase 2 dose

21 days per cycle

1 visit every 3 weeks

Dose Confirmation

Evaluate preliminary efficacy and further assess safety and tolerability of farletuzumab ecteribulin

21 days per cycle

1 visit every 3 weeks

Dose Optimization Part A

Evaluate different treatment regimens and use of oral corticosteroids for safety and efficacy

21 days per cycle

1 visit on Days 1, 8, and 15

Dose Optimization Part B

Further evaluate selected treatment regimens for safety and efficacy in advanced EC

21 days per cycle

1 visit per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid
• Farletuzumab ecteribulin
• MORAb-202

Trial Overview

The trial is testing Farletuzumab Ecteribulin's safety and effectiveness in different doses for selected tumors. It includes dose-escalation to find the best dose, confirmation of preliminary efficacy in ovarian and endometrial cancers, and optimization to assess other treatment regimens.

How Is the Trial Designed?

Group I: Dose Optimization Part B: Farletuzumab ecteribulin + Lenvatinib Experimental Treatment 2 Interventions

Participants with OC will either receive farletuzumab ecteribulin (MORAb-202) monotherapy as an intravenous infusion or in combination with lenvatinib, orally in a 21-day cycle.

Group II: Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulin Experimental Treatment 1 Intervention

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on two different days in a 21-day cycle.

Group III: Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulin Experimental Treatment 1 Intervention

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on three different days in a 21-day cycle.

Group IV: Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral Corticosteroids Experimental Treatment 4 Interventions

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion and oral corticosteroids in a 21-day cycle.

Group V: Dose Escalation Part: Farletuzumab ecteribulin Experimental Treatment 1 Intervention

Participants with selected tumor types will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.

Group VI: Dose Confirmation Part: Farletuzumab ecteribulin Experimental Treatment 1 Intervention

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

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

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04300556

NCT04300556 | A Study to Evaluate the Safety, Tolerability ...

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)- ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11638381/

Efficacy and Safety of Farletuzumab in Ovarian Cancer

Farletuzumab appears to offer a promising efficacy profile, particularly in ovarian cancer, with notable improvements in disease progression and survival.

3.

eisai.com

eisai.com/news/2022/news202245.html

EISAI PRESENTS NEW FINDINGS FOR ANTIBODY DRUG ...

The dose-escalation part of Study 101 suggested that treatment with farletuzumab ecteribulin led to antitumor activity in patients with FRα- ...

4.

asco.org

asco.org/abstracts-presentations/ABSTRACT364704

Safety and efficacy of MORAb-202 in patients (pts) with ...

The dose-escalation part of this phase 1 study confirmed antitumor activity in pts with ovarian cancer (Shimizu 2021, CCR); based on efficacy and safety, MORAb ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.5513

Safety and efficacy of MORAb-202 in patients (pts) with ...

The dose-escalation part of this phase 1 study confirmed antitumor activity in pts with ovarian cancer (Shimizu 2021, CCR); based on efficacy ...

6.

eisaimedicalinformation.com

eisaimedicalinformation.com/-/media/Files/EisaiMedicalInformation/Oncology/Congress-Materials/AACR-2023/Wenham-RM_AACR-2023_MORAb-201-TIP-update_Poster_FINAL.pdf?hash=86f60729-37af-4ce0-84ad-97b29cab3679

A multicentre, open-label phase 1/2 trial evaluating the ...

After the data cutoff date, 1 patient in the 0.9 mg/kg cohort died and was considered to have a lung disorder (not otherwise specified) related to treatment ...