2024 World Conference on Lung Cancer (WCLC) - Posters-P3.12D.09 Trial in Progress: A Phase Ib Study of HMBD-001, An Anti-HER3 Antibody, in Advanced Squamous Non-Small Cell Lung Cancer

P3.12D.09 Trial in Progress: A Phase Ib Study of HMBD-001, An Anti-HER3 Antibody, in Advanced Squamous Non-Small Cell Lung Cancer

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The document outlines a Phase Ib study investigating the safety, tolerability, and preliminary efficacy of HMBD-001, an anti-HER3 antibody, in combination with docetaxel, with or without cetuximab, in patients with advanced squamous cell carcinoma, particularly non-small cell lung cancer (sqNSCLC). The study is being conducted at multiple locations in Australia and Singapore. <br /><br />The trial comprises three cohorts:<br /><br />1. **Cohort A:** Closed to recruitment; focused on HMBD-001 with docetaxel in sqNSCLC.<br />   <br />2. **Cohort B:** Evaluates HMBD-001 with docetaxel and cetuximab in advanced or metastatic sqNSCLC patients who have undergone previous treatments. With a sample size using the Simon 2-stage optimal design, it focuses on safety, tolerability, and efficacy outcomes like the overall response rate (ORR), disease control rate (DCR), and survival metrics.<br />   <br />3. **Cohort C:** Aims to assess the combination of HMBD-001 and cetuximab in various squamous cell carcinomas without chemotherapy, targeting advanced/metastatic settings with past lines of systemic therapy.<br /><br />Eligibility criteria include:<br />- Patients aged 18+ with measurable disease by RECIST 1.1.<br />- Patients with specific past treatment histories and performance statuses.<br />- Exclusion of prior treatment with other EGFR or HER3 targeting agents.<br /><br />The study highlights potential benefits of dual inhibition of EGFR and HER3 pathways in squamous cell carcinomas due to genetic aberrations like the amplification of Chr 3q and loss of Chr 3p, which contribute to resistance to purely EGFR-targeted therapies.<br /><br />HMBD-001 has shown promising preclinical efficacy when combined with cetuximab, and further enhanced with docetaxel. Additionally, separate trials in prostate cancer and HER3 signaling aberrations are exploring its broader applications.<br /><br />This study is conducted in collaboration with Merck KGaA, under a supply agreement for cetuximab, and acknowledges the contributions of participating patients and institutions.

Asset Subtitle

Alejandro Mas Fernandez

Meta Tag

Speaker Alejandro Mas Fernandez

Topic Metastatic NSCLC – Targeted Therapy

Keywords

Phase Ib study

HMBD-001

anti-HER3 antibody

squamous cell carcinoma

non-small cell lung cancer

docetaxel

cetuximab

EGFR inhibition

clinical trial

Australia and Singapore