Phase 12 Study of Farletuzumab Ecteribulin MORAb-202 for Safety and Effectiveness in Adults With Selected Cancers Including Ovarian, Endometrial, Lung, and Triple-Negative Breast Cancer

What this Trial Is About

Researchers are studying farletuzumab ecteribulin MORAb-202, a folate receptor alpha-targeting antibody-drug conjugate, in participants with selected solid tumors including ovarian cancer, endometrial cancer, non-small cell lung carcinoma, and triple-negative breast cancer. The study aims to evaluate safety, tolerability, and determine recommended doses in early phases, then assess preliminary effectiveness and further safety in later phases. Various treatment regimens and combinations with lenvatinib are also being explored to optimize dosing. Participants receive farletuzumab ecteribulin intravenously every three weeks in 21-day cycles. Some groups receive additional oral corticosteroids after each dose or different infusion schedules within the cycle. In one part, ovarian cancer participants receive either farletuzumab ecteribulin alone or combined with oral lenvatinib. The study includes dose escalation, dose confirmation, and dose optimization parts with separate cohorts for specific tumor types and treatment regimens. During the study, participants undergo regular assessments including tumor imaging to measure response, laboratory tests, vital signs, and ECGs to monitor safety. Researchers track adverse events, dose-limiting toxicities, and pharmacokinetics of the study drug. Outcome measures include objective response rate, duration of response, progression-free survival, overall survival, and clinical benefit rates, with follow-up lasting up to approximately five years after treatment initiation.

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