Farletuzumab Ecteribulin for Solid Cancers

Recruiting at 41 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

142 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[EC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Dose Optimization Part B, Cohort 2: Farletuzumab ecteribulin Experimental Treatment 1 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 ecteribulin Experimental Treatment 1 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 ecteribulin Experimental Treatment 1 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 ecteribulin Experimental Treatment 1 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 Corticosteroids Experimental Treatment 4 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 ecteribulin Experimental Treatment 1 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 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 days 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