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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Eisai Inc.
Study ID
NCT04300556
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Farletuzumab ecteribulin — DRUG
    Farletuzumab ecteribulin intravenous infusion.
  • Prednisone — DRUG
    Prednisone administered orally.
  • Prednisolone — DRUG
    Prednisolone administered orally.
  • Dexamethasone — DRUG
    Dexamethasone administered orally.
  • Lenvatinib — DRUG
    Lenvatinib administered orally.

Study Details

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 \[OC only\]): 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 addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.

Key Dates

Start date
Aug 6, 2020
Status verified
Jun 2026
Primary completion
Aug 8, 2030
Completion
Aug 8, 2030

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Part: Farletuzumab ecteribulin
    Participants with selected tumor types will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
  • Experimental: Dose Confirmation Part: Farletuzumab ecteribulin
    Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
  • Experimental: Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral Corticosteroids
    Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion and oral corticosteroids in a 21-day cycle.
  • Experimental: Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulin
    Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on three different days in a 21-day cycle.
  • Experimental: Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulin
    Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on two different days in a 21-day cycle.
  • Experimental: Dose Optimization Part B: Farletuzumab ecteribulin + Lenvatinib
    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.

Primary Outcome Measure

Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin [ Time Frame: Cycle 1 (Cycle length is equal to [=] 21 days) ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
ACRC/Arizona Clinical Research Center, IncTucsonArizona85715-
Universty of Arkansas for Medical SciencesLittle RockArkansas72205-
Stanford Women's Cancer CenterPalo AltoCalifornia94304-
University of MiamiCoral GablesFlorida33146-
Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Winship Cancer InstituteAtlantaGeorgia30322-
Georgia Cancer CenterAugustaGeorgia30912-
Northwestern Memorial HospitalChicagoIllinois60611-
Ascension Illinois-Skokie Infustion CenterSkokieIllinois60077-
Norton HealthcareLouisvilleKentucky40202-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
Henry Ford HospitalDetroitMichigan48202-
Karmanos Cancer InstituteDetroitMichigan48201-
MD Anderson Cancer Center at CooperCamdenNew Jersey08103-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Cincinnati Medical CenterCincinnatiOhio45219-
OSU Wxner Medical CenterHilliardOhio43026-
Oregon Health & Science UniversityPortlandOregon97239-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Chattanooga's Program in Women's OncologyChattanoogaTennessee37403-
Vanderbilt University Medical CenterNashvilleTennessee07677-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Tucson, AZ

By research site
ACRC/Arizona Clinical Research Center, Inc· Tucson, AZUniversty of Arkansas for Medical Sciences· Little Rock, ARStanford Women's Cancer Center· Palo Alto, CAUniversity of Miami· Coral Gables, FLMoffitt Cancer Center and Research Institute· Tampa, FLWinship Cancer Institute· Atlanta, GA

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