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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to approximately 4 years 8 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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I am 18 years old or older.

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

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

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

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

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

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My cancer can be measured by tests or scans.

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin

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)

+1 more

Secondary outcome measures

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

Change From Baseline in Oxygen Saturation (SpO2)

Clinical Benefit Rate (CBR)

+12 more

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

Dexamethasone

2007

Completed Phase 4

~2590

Prednisone

2014

Completed Phase 4

~2370

Prednisolone

2005

Completed Phase 4

~2720

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,128,858 Total Patients Enrolled

Eisai Inc.Lead Sponsor

515 Previous Clinical Trials

153,840 Total Patients Enrolled

Media Library

Farletuzumab ecteribulin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04300556 — Phase 1 & 2

Solid Tumors Research Study Groups: Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral Corticosteroids, Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulin, Dose Optimization Part B, Cohort 1: Farletuzumab ecteribulin, Dose Confirmation Part: Farletuzumab ecteribulin, Dose Optimization Part B, Cohort 2: Farletuzumab ecteribulin, Dose Escalation Part: Farletuzumab ecteribulin, Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulin

Solid Tumors Clinical Trial 2023: Farletuzumab ecteribulin Highlights & Side Effects. Trial Name: NCT04300556 — Phase 1 & 2

Farletuzumab ecteribulin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04300556 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any Canadian treatment centers presently executing this exploration?

"Currently, this medical trial is seeking participants from 9 distinct sites. These locations span Stanford, New york and Camden amongst other cities - so you can choose the location that requires minimal travel if you decide to join."

Answered by AI

Is the enrollment period for this research study still open?

"As indicated on clinicaltrials.gov, recruitment for this medical trial remains ongoing; the study being first published on August 6th 2020 and most recently amended on October 31st 2022."

Answered by AI

How many volunteers are contributing to this clinical research?

"Eisai Inc., the sponsor of this trial, needs to find 55 qualified participants in order for it to be executed. The trial locations include Stanford University School of Medicine (Stanford, California) and Columbia University Medical Center (New york)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

2020. "A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300556.