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

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

Trial Details

NCT ID
NCT04300556
Phase
PHASE1 / PHASE2
Sponsor
Eisai Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Farletuzumab ecteribulin
  • Prednisone
  • Prednisolone
  • Dexamethasone
  • Lenvatinib
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Palo Alto, California, United States|37.44188,-122.14302
  • Coral Gables, Florida, United States|25.72149,-80.26838
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Aged \>=18 years
  • For Dose-Escalation: Females (TNBC, EC and OC) or males/females (NSCLC, adenocarcinoma). Participants with the following disease characteristics:
  • Participants with the following tumor types, each as a separate arm:
  • TNBC: Histologically confirmed diagnosis of metastatic TNBC (that is, estrogen receptor (ER) negative/progesterone receptor negative/ human epiderm…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Small Cell (NSCLC) Lung Cancer Trials on Trialify →