← Back to Search

Monoclonal Antibodies

Farletuzumab Ecteribulin for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Endometrial cancer participants with histologically confirmed diagnosis of advanced, recurrent, or metastatic EC

Participants with TNBC: Histologically confirmed diagnosis of metastatic TNBC, previously treated with at least one line of systemic anticancer therapy in the metastatic setting

Must not have

Participants receiving any prohibited medication in combination with the study treatment(s)

Participants with brain or subdural metastases unless specific criteria are met

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to approximately 4 years 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to people with ovarian, endometrial, lung, or breast cancer. The trial will test different doses of the drug to see what is the best dose to give to people.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation of organs; infusion-related reactions; fatigue; digestive problems like nausea; blood disorders that can affect clotting or immunity; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My endometrial cancer is advanced, recurrent, or has spread to other parts.

Select...

I have triple-negative breast cancer and have received at least one treatment for it after it spread.

Select...

I am 18 years old or older.

Select...

My lung cancer has spread and previous treatments didn't work.

Select...

I have high-grade ovarian, peritoneal, or fallopian tube cancer that is resistant to platinum-based treatments.

Select...

I've had up to 4 treatments after my cancer stopped responding to platinum-based therapy.

Select...

My ovarian, peritoneal, or fallopian tube cancer is resistant to platinum-based treatments.

Select...

My cancer has worsened after my last treatment, as confirmed by scans.

Select...

My cancer can be measured by tests or scans.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have completed a break period after my last treatment before starting the study drug.

Select...

My EC has come back or spread and treatments I've tried didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have brain metastases but meet specific criteria for treatment.

Select...

I have a serious heart condition.

Select...

I have active viral hepatitis.

Select...

I am not pregnant or breastfeeding.

Select...

I currently have or have had viral pneumonia.

Select...

My ovarian cancer did not respond to platinum-based chemotherapy.

Select...

I have had chest radiotherapy in the past.

Select...

I have had another cancer that needed treatment or got worse recently.

Select...

I have or might have lung inflammation.

Select...

I currently have a serious infection.

Select...

I have a serious lung condition.

Select...

I have had a pneumonectomy.

Select...

I have an active case of tuberculosis.

Select...

I am scheduled for surgery during the study period.

Select...

I have fluid buildup around my lungs or heart.

Select...

I am not currently in another study or haven't used experimental drugs or devices recently.

Select...

I have a type of soft tissue sarcoma related to the uterus.

Select...

I am a woman who can have children and do not follow the contraceptive guidelines.

Select...

I am allergic to certain antibody medications or cannot take corticosteroids.

Select...

I have been diagnosed with cancer that has spread to the lining of my brain and spinal cord.

Select...

I have been treated with drugs targeting the folate receptor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to approximately 4 years 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to approximately 4 years 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to approximately 4 years 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose-limiting Toxicities (DLTs)

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Treatment Discontinuation and Adverse Events of Interest (AEIs)

Objective Response Rate (ORR)

Secondary study objectives

Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Change From Baseline in Oxygen Saturation (SpO2)

Clinical Benefit Rate (CBR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Optimization Part B, Cohort 2: Farletuzumab ecteribulinExperimental Treatment1 Intervention

Participants with EC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, at a dosing regimen identified during Part A.

Group II: Dose Optimization Part B, Cohort 1: Farletuzumab ecteribulinExperimental Treatment1 Intervention

Participants with EC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, at a dosing regimen identified during Part A.

Group III: Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulinExperimental Treatment1 Intervention

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Days 1 and 8 of every 21-day cycle.

Group IV: Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulinExperimental Treatment1 Intervention

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Days 1, 8 and 15 of every 21-day cycle.

Group V: Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral CorticosteroidsExperimental Treatment4 Interventions

Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once on Day 1 and oral corticosteroids on Days 8, 9 and 10 of every 21-day cycle.

Group VI: Dose Escalation Part: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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

Group VII: Dose Confirmation Part: Farletuzumab ecteribulinExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Prednisolone

2005