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.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
13 Primary · 23 Secondary · Reporting Duration: From date of first dose of study drug until first documentation of CR or PR (up to approximately 2 years)
Year 2
Number of Participants with Adverse Events (AEs) and Adverse Events of Interest (AEIs)
Number of participants with Clinically Significant Change From Baseline in Clinical Laboratory Values, Vital Signs, Body Weight and 12-lead Electrocardiograms
Year 7
Investigate tumor Folate Receptor Alpha (FRA) expression levels association with and predictive power for clinical outcomes (objective response and progression free survival)
Relationship Between Folate Receptor Alpha (FRA) Expression Levels and Clinical Outcome
Year 9
Number of Participants With Adverse Events (AEs) and Adverse Events of Interest (AEIs)
Year 4
Percentage of Participants With Interstitial Lung Disease (ILD)
Percentage of Participants With Severity of ILD Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time to Onset of ILD Symptoms
Time to Resolution of ILD Symptoms
Year 8
Change From Baseline in Oxygen Saturation (SpO2)
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values, Vital Signs, Body Weight and 12-lead Electrocardiograms
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Treatment Discontinuation and Adverse Events of Interest (AEIs)
Year 9
Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
Year 8
Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Day 21
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Day 21
Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin
Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of MORAb-202
Day 21
Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)
Number of Participants With Dose-limiting Toxicities (DLTs)
Year 2
Number of Participants with Serum Anti-Drug Antibodies (ADA) Titer to MORAb-202
Year 4
Number of Participants With Serum Anti-Drug Antibodies (ADA) Titer to MORAb-202
Year 8
Number of Participants With Serum Anti-Drug Antibodies (ADA) Titer to Farletuzumab Ecteribulin
Day 21
Pharmacokinetics (PK) Profiles of MORAb-202
Day 28
Total Antibody Concentration for Eribulin and Farletuzumab Ecteribulin
Total Antibody Concentration for Eribulin and MORAb-202
Year 2
Dose Expansion Part: Objective Response Rate (ORR)
Week 24
Objective Response Rate (ORR)
Year 8
Duration of Response (DOR)
Year 8
Overall Survival (OS)
Year 8
Clinical Benefit Rate (CBR)
Year 8
Progression Free Survival (PFS)
Year 8
Disease Control Rate (DCR)
Hour 336
PK Profiles: Area Under the Serum Concentration-time Curve From 0 to Infinity (AUC[0-∞]) for Farletuzumab Ecteribulin
PK Profiles: Terminal Elimination Phase Half-life (t½) for Farletuzumab Ecteribulin
PK Profiles: Time of Cmax (tmax) for Farletuzumab Ecteribulin
Pharmacokinetics (PK) Profiles: Maximum Observed Serum Concentration (Cmax) for Farletuzumab Ecteribulin
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
9 Treatment Groups
Dose Confirmation Part: MORAb-202 (0.9 mg/kg) With Corticosteroid Pretreatment
1 of 9
Dose Confirmation Part: Farletuzumab ecteribulin (25 mg/m^2)
1 of 9
Dose Confirmation Part: MORAb-202 (33 mg/m^2)
1 of 9
Dose Confirmation Part: MORAb-202 (25 mg/m^2)
1 of 9
Dose Confirmation Part: MORAb-202 (1.2 mg/kg) With Corticosteroid Pretreatment
1 of 9
Dose Confirmation Part: MORAb-202 (0.9 mg/kg) Without Corticosteroid Pretreatmen...
1 of 9
Dose Escalation: Farletuzumab ecteribulin
1 of 9
Dose Escalation: MORAb-202
1 of 9
Dose Confirmation Part: Farletuzumab ecteribulin (33 mg/m^2)
1 of 9
Experimental Treatment
55 Total Participants · 9 Treatment Groups
Primary Treatment: Farletuzumab ecteribulin · No Placebo Group · Phase 1 & 2
Dose Confirmation Part: MORAb-202 (0.9 mg/kg) With Corticosteroid PretreatmentExperimental Group · 2 Interventions: Corticosteroid, MORAb-202 · Intervention Types: Drug, Drug
Dose Confirmation Part: Farletuzumab ecteribulin (25 mg/m^2)
Drug
Experimental Group · 1 Intervention: Farletuzumab ecteribulin · Intervention Types: DrugDose Confirmation Part: MORAb-202 (33 mg/m^2)
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: DrugDose Confirmation Part: MORAb-202 (25 mg/m^2)
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: DrugDose Confirmation Part: MORAb-202 (1.2 mg/kg) With Corticosteroid PretreatmentExperimental Group · 2 Interventions: Corticosteroid, MORAb-202 · Intervention Types: Drug, Drug
Dose Confirmation Part: MORAb-202 (0.9 mg/kg) Without Corticosteroid Pretreatment
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: DrugDose Escalation: Farletuzumab ecteribulin
Drug
Experimental Group · 1 Intervention: Farletuzumab ecteribulin · Intervention Types: DrugDose Escalation: MORAb-202
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: DrugDose Confirmation Part: Farletuzumab ecteribulin (33 mg/m^2)
Drug
Experimental Group · 1 Intervention: Farletuzumab ecteribulin · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroid
2005
Completed Phase 4
~2100
MORAb-202
2017
Completed Phase 1
~90
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of first dose of study drug until first documentation of cr or pr (up to approximately 2 years)
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
511 Previous Clinical Trials
151,642 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have already received four rounds of treatment for your condition after becoming resistant to platinum-based therapy.
You have had up to three rounds of treatment for your condition, and it is deemed appropriate for you to receive a single medication as your next treatment option. You may have had one additional round of treatment after it was determined your body was resistant to platinum-based treatments.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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)." - Anonymous Online Contributor
Unverified Answer