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(Slides)

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The document discusses a Phase 1/2 clinical trial evaluating the efficacy of Ozuriftamab Vedotin (BA3021) alone and in combination with nivolumab in patients with advanced solid tumors. BA3021 is a conditionally active biologic (CAB) monoclonal antibody that targets the receptor tyrosine kinase-like orphan receptor 2 (ROR2), which is overexpressed in various tumor types. <br /><br />The study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3021. The trial includes two phases: dose escalation and dose expansion. The maximum tolerated dose and/or initial phase 2 dose will be identified during dose escalation. The efficacy and safety of BA3021 alone and in combination with nivolumab will be evaluated during the dose expansion phase. <br /><br />The study also explores various endpoints, including overall response rate, duration of response, progression-free survival, overall survival, and changes in tumor size. Tumor assessments will be conducted periodically, and adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. <br /><br />It is hypothesized that targeting ROR2 with BA3021 may lead to antitumor activity in non-small cell lung cancer (NSCLC) and other tumor types. ROR2 also appears to play a role in resistance and recurrence in tumors that are resistant to programmed cell death-1 (PD-1) inhibitors. <br /><br />Preclinical data supports the potential antitumor activity of BA3021 in various tumor types, and the development of CABs aims to improve pharmacokinetics, reduce off-tumor toxicity, and avoid tissue-mediated drug deposition. The study of BA3021 is sponsored by BioAtla, and the trial locations include several countries such as the United States, China, Taiwan, Germany, Poland, Spain, Italy, and Greece.

Asset Subtitle

Mariam Alexander

Meta Tag

Speaker Mariam Alexander

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

Phase 1/2 clinical trial

Ozuriftamab Vedotin

BA3021

nivolumab

advanced solid tumors

ROR2

dose escalation

antitumor activity

NSCLC

PD-1 inhibitors