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A Phase 2, Multi-Center, Open Label Study of NIR178 in Combination with PDR001 in Patients with Selected Advanced Solid Tumors and Non-Hodgkin lymphoma
The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.
Primary: Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). Part 2: To assess the efficacy several intermittent dosing schedules of NIR178 in combination with PDR001 in NSCLC. Part 3: To evaluate efficacy of intermittent dosing schedule of NIR178 in NSCLC and another tumor type. Secondary: - To assess efficacy of NIR178+PDR001 in select advanced solid tumors and lymphoma. - To assess the safety and tolerability of the NIR178 and PDR001 combination. - To characterize changes in the immune infiltrate in tumors. - To characterize the pharmacokinetics (PK) of NIR178, its metabolite NJI765 and PDR001 in combination. - To assess immunogenicity of PDR001. Exploratory: - To assess the pharmacodynamic (PD) effect of NIR178 alone and in combination with PDR001 in tumor tissue and peripheral blood. - To assess potential predictors of efficacy of NIR178 in combination with PDR001.