Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Required: PD-L1 (CD274) PD-(L)1-naïve

advanced PD-(L)1-naïve MSS colorectal cancer (CRC)

Required: PD-L1 (CD274) PD-1 relapsed/refractory

PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients

Required: MSH2 microsatellite stable

MSS colorectal cancer (CRC), MSS endometrial cancer (EC)

Must have received: systemic therapy

refractory to standard therapy or for which no standard therapy exists

Cannot have received: biological agent (monoclonal antibody, immunotherapy)

biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805

Cannot have received: chemotherapy

chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C

Cannot have received: targeted small molecule therapy

chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C

Cannot have received: hormonal therapy

chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C

Cannot have received: radiation therapy

chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C

Cannot have received: nitrosourea

within 42 days for nitrosoureas and mitomycin C

Cannot have received: mitomycin C (mitomycin C)

within 42 days for nitrosoureas and mitomycin C

Cannot have received: anti-SIRPα therapy

anti-SIRPα or anti-CD47-directed therapy

Cannot have received: anti-CD47 therapy

anti-SIRPα or anti-CD47-directed therapy

Cannot have received: systemic chronic steroid therapy

systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805

Cannot have received: immunosuppressive therapy

systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805

Cannot have received: investigational new drug

other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805

Cannot have received: investigational device

other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805

Cannot have received: live virus vaccine

vaccine containing live virus within 28 prior to the first dose of ADU-1805