A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors (NCT07070232)

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Mark Voskoboynik

Key inclusion data

Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be considered met when advanced disease derives from unequivocal progression of a previously biopsied site of disease (e.g., progression of residual tumor after concomitant chemo-radiation for Stage III NSCLC). Cohort 1A: Cutaneous melanoma (second-line or higher [2L+]). Cohort 1B: Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC) 2L+. Cohort 1C: Epithelial growth factor receptor mutated (EGFRm) NSCLC 2L+. Cohort 1D: Rare melanoma (acral/uveal/mucosal melanoma). Cohort 1E: Other advanced solid tumors. Cohort 1F (drug-drug interaction [DDI] Cohort): Advanced solid tumors. Cohort 2A: Cutaneous melanoma 2L+. Cohort 2B: Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.