NCT05856981

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Sairopa B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Solid Tumor, Adult
• Metastatic Solid Tumor
• Refractory Cancer
• CRC, Colorectal Cancer
• RCC, Clear Cell Adenocarcinoma
• NSCLC (Advanced Non-small Cell Lung Cancer)
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	ADU-1805	anti-SIRPα monoclonal antibody
DRUG	Pembrolizumab	Keytruda

Timeline

• Start date: 2023-04-03
• Primary completion: 2027-05-01
• Completion: 2027-07-01
• First posted: 2023-05-12
• Last updated: 2025-12-17

Locations

7 sites across 3 countries: United States, Belgium, Spain

Regulatory

• FDA-regulated drug study