Spots Global Cancer Trial Database for Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

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Trial Identification

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

Official Title: An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors

Study ID: NCT05856981

Conditions

Solid Tumor, Adult

Metastatic Solid Tumor

Refractory Cancer

Interventions

ADU-1805

Pembrolizumab

Study Description

Brief Summary: 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).

Detailed Description: The study will start with the ADU-1805 monotherapy dose escalation arm following an i3+3 design until the RP2D is defined. The ADU-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the ADU-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the RP2D for the combination is defined.