Trial intelligence / Profile preview

MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer

NCT05188209Phase 2

Key facts

Status: Terminated
Start: Dec 2021
Primary completion: Oct 2022
Countries: 1
Sponsor: Lepu Biopharma Co., Ltd.
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)

Drugs: becotatug vedotin
Conditions: gastric cancer (GC)gastroesophageal junction carcinoma (GEJ)

Overview

Phase 2, open-label, single-arm trial of becotatug vedotin in gastric cancer (GC) and gastroesophageal junction carcinoma (GEJ), sponsored by Lepu Biopharma Co., Ltd. Primary endpoints: Objective Response Rate by Independent Review Committee up to 24 months and Adverse Events up to 45 days. Started Dec 2021; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

MRG003
MRG003 administered via intravenous infusion at 2.0 mg/kg every 3 weeks

Who it enrols

Patients aged 18-75 with inoperable locally advanced or metastatic gastric adenocarcinoma that is EGFR-positive and HER2-negative, with measurable lesions, ECOG 0-1, and adequate organ function.

Endpoints

Primary

Objective Response Rate by Independent Review Committeeup to 24 months
Adverse Eventsup to 45 days

Secondary

Objective Response Rate by Investigatorup to 24 months
Progression Free Survivalup to 24 months
Duration of Responseup to 24 months
Disease Control Rateup to 24 months
Overall Survivalup to 24 months
Maximum Observed Plasma Concentration for MRG003up to 30 days
Area Under the Curve from Time Zero to Last Quantifiable Concentration for MRG003up to 30 days
Maximum Observed Plasma Concentration for Total Antibodyup to 30 days

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