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A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability and Efficacy of MORAb-202, a Folate Receptor Alpha (FRA)-Targeting Antibody-Drug Conjugate (ADC) in Subjects with Selected Tumor Types
The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety, tolerability and to determine the recommended Phase 2 dose (RP2D) of MORAb-202, and (2) in an expansion part: to evaluate the objective response rate (ORR) in each of the selected tumor types at the RP2D.
Dose Escalation Primary Objective: To evaluate safety, tolerability and to determine the recommended Phase 2 dose (RP2D) of MORAb-202 in subjects with selected tumor types. Expansion Part Primary Objectives: To evaluate the objective response rate (ORR) in each of the selected tumor types at the RP2D. To further evaluate the safety and tolerability of MORAb-202. Secondary Objectives: To evaluate duration of response (DOR), disease control rate (DCR), and clinical benefit rate (CBR) in each tumor type. To evaluate progression-free survival (PFS) and overall survival (OS) in each tumor type. To determine the pharmacokinetic (PK) profiles of MORAb-202, total antibody, and released eribulin in serum and plasma in the tumor types combined. To evaluate the relationship between folate receptor alpha (FRA) expression levels and clinical outcome measures to support the identification of an appropriate FRA cut off point for each tumor type. Exploratory Objectives: To explore potential blood and tumor pharmacodynamics (PD) biomarkers (eg, soluble FRA), and correlate with clinical outcome measures including PK, safety, and efficacy. To investigate the effect of MORAb-202 on ventricular repolarization (Dose-Escalation Part only). To evaluate the PD effects and predictive biomarkers of MORAb-202 by examining genomic DNA, RNA, serum, plasma, circulating tumor cells (CTCs), urine, or archived tumor tissue to identify molecular or other biomarkers for therapy response. To evaluate the relationship between lines of prior therapy and clinical outcome measures (ovarian cancer only).