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(Abstract)

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This abstract discusses the first-in-human study of the novel antibody-drug conjugate AZD9592 in patients with advanced solid tumors. The study aims to evaluate the safety, tolerability, efficacy, and pharmacokinetics of AZD9592 as monotherapy and in combination with osimertinib in patients with metastatic non-small cell lung cancer (NSCLC) and recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). AZD9592 is an ADC with a bispecific antibody targeting the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition tyrosine kinase receptor (cMET). It releases a topoisomerase 1 inhibitor (TOP1i) payload that induces apoptotic cell death.<br /><br />The study consists of two modules. Module 1 evaluates AZD9592 monotherapy in patients with metastatic NSCLC with EGFR mutations or EGFR wild-type, as well as patients with recurrent or metastatic HNSCC. Module 2 evaluates AZD9592 in combination with osimertinib in patients with EGFR-mutated NSCLC. Each module includes dose escalation and dose expansion cohorts.<br /><br />The primary objectives of the study are to assess the safety and tolerability of AZD9592, determine the maximum tolerated dose and/or recommended Phase 2 dose, and evaluate antitumor activity. Secondary objectives include evaluating efficacy (objective response rate, disease control rate, duration of response, and survival), pharmacokinetics, and immunogenicity.<br /><br />The study includes sites across the EU, USA, and Asia Pacific, and as of March 2023, two patients have been enrolled in the USA and Australia.<br /><br />This research provides valuable insights into the potential use of AZD9592 as a targeted therapy for EGFR-positive NSCLC and HNSCC.

Asset Subtitle

Sally Lau

Meta Tag

Speaker Sally Lau

Topic Metastatic NSCLC: Cytotoxic Therapy

Keywords

antibody-drug conjugate

AZD9592

solid tumors

safety

efficacy

monotherapy

combination therapy

EGFR

dose escalation

targeted therapy