This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).
This study is designed to evaluate the safety, PK, PD and preliminary clinical activity of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody). The study is divided into a dose escalation phase and a dose expansion phase. The dose expansion phase investigates ADU-1805 plus pembrolizumab at the respective recommended phase 2 dose (RP2D) in four advanced solid tumors: advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
anti-SIRPα monoclonal antibody
Keytruda
Henry Ford Cancer Institute
Detroit, Michigan, United States
RECRUITINGWashington University Medical Campus
St Louis, Missouri, United States
RECRUITINGGabrail Cancer & Research Center
Canton, Ohio, United States
RECRUITINGVirginia Cancer Specialists
Fairfax, Virginia, United States
RECRUITINGGrand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi, Belgium
RECRUITINGHosp 12 de Octubre
Madrid, Spain
RECRUITINGHospital General Universitario Gergorio Maranon
Madrid, Spain
RECRUITINGEscalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0
Time frame: First 21 days of treatment
Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.
Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Through study completion, up to 2,5 years
Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters
Serum concentration-time profiles and PK parameters (including Cmax, AUC)
Time frame: Through study completion, up to 2,5 years
Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Incidence of anti-ADU-antibodies
Time frame: Through study completion, up to 2,5 years
Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion
Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters.
Time frame: Through study completion, up to 2,5 years
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