The US Food and drug administration (FDA) has granted fast track designation to antibody conjugate (ADC) CMG901 as a single-agent treatment for gastric and gastroesophageal junction (GEJ) cancer patients with unresectable or metastatic disease that is relapsed or refractory to approved therapies.
CMG901 is an ADC that binds to claudin 18.2 positive cells. Once the conjugate is internalised, it results in cytotoxicity and cell death of claudin 18.2-positive cancer cells. The preclinical data of CMG901 suggests its potency in removing cancer cells than the zolbetuximab analogue or unconjugated antibody of CMG901. Moreover, the ADC has acceptable tolerability.
The FDA designation is based on the data from the earlier conducted preclinical study on gastric cancer patients. The preclinical study was conducted in two parts. The first part comprised of dose escalation studies where CMG901 was administered once every 3 weeks in a modified 3+3 escalation design (1.2 mg/kg, 1.8 mg/kg, 2.2 mg/kg, 2.6 mg/kg, and 3.0 mg/kg). Based on the maximum tolerable dose (MTD) estimation from part A, patients were administered CMG901 intravenously on day 1 of every 21-day cycle in the next part of the study.
The primary endpoints of the dose-escalation part included dose-related toxicities and treatment emerge adverse effects (TEAE). Further, the primary objective of the second part was to measure the objective response rate as per the RECIST v1.1 criteria and establish the recommended phase 2 dose of the agent.
The FDA fast track designation is vital in finishing the pivotal trial design in Claudin 18.2–positive advanced gastric and GEJ adenocarcinomas.
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