CDSCO Panel Approves AstraZeneca's Protocol Amendment for Anti-cancer Drug AZD0901 study
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organisation (CDSCO), has approved AstraZeneca Pharma India's proposal for protocol amendment of the clinical trial of AZD0901 powder for solution for infusion.
This came after the firm presented protocol Amendment version 2.0 dated 20 Aug 2024, protocol no. D9802C00001.
This is a phase III multi-center, open-label, sponsor-blinded, randomized study of AZD0901 monotherapy compared with the investigator’s choice of therapy in second- or later-line adult participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing claudin18.2 (CLARITYGASTRIC01).”
AZD0901 is a drug being developed by AstraZeneca to treat advanced solid tumors, such as pancreatic cancer, gastric cancer, and adenocarcinoma of the gastroesophageal junction. AZD0901 specifically targets and binds to CLDN18. 2 expressed on tumor cells. Upon internalization and the release of MMAE, MMAE targets and binds to tubulin and inhibits microtubule polymerization. This results in G2/M phase cell cycle arrest and apoptosis in CLDN18.
At the recent SEC meeting for oncology, the expert panel reviewed the protocol Amendment version 2.0 dated 20 Aug 2024, protocol no. D9802C00001.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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