RecruitingPhase 1NCT05856981

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


Sponsor

Sairopa B.V.

Enrollment

130 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study testing a new cancer drug called ADU-1805 — which targets a protein that helps tumors hide from the immune system — in people with advanced solid tumors (cancers that have spread and are no longer responding to standard treatment). **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of an advanced or metastatic solid tumor cancer that is no longer responding to standard therapies, or for which no standard therapy exists - You are in generally good health (ECOG performance status 0 or 1) - For the expansion phase: you have colorectal cancer (MSS type without liver spread), endometrial cancer, kidney cancer, or non-small cell lung cancer that has progressed on immunotherapy **You may NOT be eligible if...** - You have melanoma, brain tumors (including glioblastoma), sarcoma, or pancreatic ductal cancer (dose escalation phase) - You are pregnant or breastfeeding - You have received more than 3 prior lines of treatment (expansion phase) - You have serious autoimmune disease or have recently received immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADU-1805

anti-SIRPα monoclonal antibody

DRUGPembrolizumab

Keytruda


Locations(7)

Henry Ford Cancer Institute

Detroit, Michigan, United States

Washington University Medical Campus

St Louis, Missouri, United States

Gabrail Cancer & Research Center

Canton, Ohio, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame

Charleroi, Belgium

Hosp 12 de Octubre

Madrid, Spain

Hospital General Universitario Gergorio Maranon

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT05856981


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