2023 World Conference on Lung Cancer (Posters)-P2.04. EGRET: First-in-human Study of the Novel Antibody-drug Conjugate AZD9592 ± Anti-cancer Agents in Advanced Solid Tumours

P2.04. EGRET: First-in-human Study of the Novel Antibody-drug Conjugate AZD9592 ± Anti-cancer Agents in Advanced Solid Tumours - PDF(Slides)

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The study presented at the 2023 World Conference on Lung Cancer focused on the first-in-human study of AZD9592, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors. The study aimed to assess the safety, tolerability, and anti-tumor activity of AZD9592 as monotherapy or in combination with other anti-cancer agents. AZD9592 targets the epidermal growth factor receptor (EGFR) and cMET, which are commonly co-expressed in various tumor types.<br /><br />The study included two modules: Module 1 evaluated AZD9592 monotherapy, while Module 2 evaluated AZD9592 in combination with osimertinib. Each module consisted of dose-escalation and dose-expansion cohorts. Additionally, pharmacodynamic (PD) backfill cohorts were included for dose levels that did not exceed the maximum tolerated dose (MTD).<br /><br />The primary objectives of the study were to assess the safety and tolerability of AZD9592, determine the MTD, and evaluate the anti-tumor activity of AZD9592 by measuring the objective response rate (ORR). Secondary objectives included assessing other measures of anti-tumor activity, characterizing the pharmacokinetics of AZD9592, and assessing its immunogenicity. Exploratory objectives looked at the PD and biological activity of AZD9592.<br /><br />The study design utilized a modified toxicity probability interval-2 algorithm for dose escalation. Patients would receive AZD9592 followed by a period of observation to assess dose-limiting toxicities. The study enrolled patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer (NSCLC), metastatic EGFR wild-type NSCLC, and recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).<br /><br />Enrollment in the study began in December 2022 and, as of July 2023, eight patients had been enrolled at sites in the USA, Australia, and the Republic of Korea.<br /><br />The study aimed to provide valuable insights into the safety, tolerability, and efficacy of AZD9592 as a potential treatment option for patients with advanced solid tumors.

Asset Subtitle

Sally Lau

Meta Tag

Speaker Sally Lau

Topic Metastatic NSCLC: Cytotoxic Therapy

Keywords

AZD9592

antibody-drug conjugate

advanced solid tumors

safety

tolerability

anti-tumor activity

monotherapy

combination therapy

epidermal growth factor receptor

cMET