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

Solid Tumor, Adult Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05856981
Study type Interventional
Source Sairopa B.V.
Contact Sairopa Clinical Team
Phone 0031 85 90 26 939
Email clinical@sairopa.com
Status Recruiting
Phase Phase 1
Start date April 3, 2023
Completion date December 2025
View Details
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