2023 World Conference on Lung Cancer (Posters)-P2.08. A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab

P2.08. A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab - PDF(Abstract)

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This document is a summary of a presentation at the WCLC (World Conference on Lung Cancer) 2023. The presentation is titled "A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab." The study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3021 in patients with advanced solid tumors, specifically ROR2-expressing tumor membrane percent score greater than or equal to 1%, metastatic Non-small Cell Lung Cancer (NSCLC), or melanoma.<br /><br />Ozuriftamab vedotin (BA3021) is a conditionally active biologic (CAB) designed to target the receptor tyrosine kinase orphan receptor 2 (ROR2) protein. Preclinical data suggest that targeting ROR2 may have antitumor activities in various tumor types, including NSCLC. The study aims to evaluate the efficacy and safety of BA3021 alone and in combination with nivolumab in patients who have experienced failure with PD-1/L-1, epidermal growth factor receptor (EGFR) inhibitor, or anaplastic lymphoma kinase (ALK) inhibitor treatments.<br /><br />The study consists of two phases. Phase 1 will include dose escalation and dose expansion to determine the maximum tolerated dose and/or recommended phase 2 dose for BA3021. Phase 2 will enroll patients with ROR2-expressing tumor membrane percent score greater than or equal to 1%, metastatic NSCLC, or melanoma who have measurable disease and documented progression according to RECIST v1.1 criteria. The primary objectives of phase 2 are to evaluate the efficacy and safety of BA3021 alone and in combination with nivolumab.<br /><br />The study is multi-center and open-label, and the enrollment is expected to be completed by 2023. The presentation highlights the potential of targeting ROR2 in treating NSCLC and the significance of the study design and objectives in understanding the antitumor activity of BA3021 and its potential in combination therapy with nivolumab.

Asset Subtitle

Mariam Alexander

Meta Tag

Speaker Mariam Alexander

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

WCLC 2023

BA3021

Nivolumab

ROR2-expressing tumor

NSCLC

melanoma

dose escalation

antitumor activity

maximum tolerated dose

combination therapy