Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First in-Human, Consecutive-Cohort, Clinical Trial of BI 1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Advanced solid tumors

Phases 1 and 2a: -Occurrence of adverse events (AEs) or serious adverse events (SAEs). -Changes from baseline in laboratory parameters, vital signs, and physical findings. - Frequency of dose interruptions and dose reductions. -Frequency of AEs leading to discontinuation of study treatment(s)., Phase 1: Occurrence of dose limiting toxicities (DLTs)., Phase 2a: Identification of dose/dose range fulfilling favorable pharmacokinetic (PK) and pharmacodynamic profile, with acceptable safety (based on the totality of the efficacy, safety, PK, and pharmacodynamic endpoint

Phases 1 and 2a: -Calculated standard PK parameters for BI 1910 (including, but not limited to, area under the serum concentration-time curve [AUC], maximum concentration [Cmax], and terminal half-life [t½]). -Incidence and titer of antidrug antibodies (ADAs)., Phase 1: RDR is defined as the range between MRAD and the MTD/MAD. MRAD is the lowest dose level at which at least 2 subjects experience ≥10% tumor shrinkage and/or relevant PK/PD parameters indicate biological activity: - Response based on RECIST 1:1 and iRECIST. - PK parameters AUC, Cmax, t½. - PD biomarkers such as TNFR2 receptor occupancy immune activation parameters, sTNFR2 and cytokine profiles, Phase 2a: - Objective response rate (ORR). - Duration of response (DoR).

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