Eisai Clinical Trials

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

MORAb-202-G000-201

Study Overview

MORAb-202
Farletuzumab ecteribulin
NCT04300556, 2019-003600-12, 2023-506868-14
Aug 2020 -
Solid Tumors
1. Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin [Time Frame: Cycle 1 (Cycle length is equal to [=] 21 days)]

2. Dose Optimization Part B: Recommended Dose (RD) of Farletuzumab Ecteribulin Monotherapy and in Combination With Lenvatinib [Time Frame: Up to approximately 5 years]

3. Objective Response Rate (ORR) [Time Frame: From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks)]

4. Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Cycle 1 (Cycle length=21 days)]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Ongoing

  • Phase 1 / 2

  • France, Japan, Spain, United Kingdom, United States See more

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR