Tests ADU-1805 alone and with pembrolizumab in advanced solid tumors
Tests ADU-1805, alone or with pembrolizumab, in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Key facts
- Where
- Charleroi, BelgiumSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors. They take ADU-1805 alone or with pembrolizumab, to test safety and how the body handles the drug.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Escalation phase: metastatic or unresectable solid tumors that did not respond to standard therapy, or with no standard therapy. Expansion phase: advanced MSS colorectal cancer not treated before with a PD-(L)1 drug, or advanced MSS endometrial cancer, renal cell carcinoma or non-small cell lung cancer that came back or did not respond to a PD-1 drug. Measurable disease is needed in the expansion phase.
- Earlier treatment
- Expansion phase: no more than 3 lines of earlier systemic treatment. Cannot have had anti-SIRPα or anti-CD47 therapy. Time gaps are required after biological agents (28 days), chemotherapy or radiation (21 days), steroids or immunosuppressants (14 days) and investigational drugs (28 days).
Main reasons for not taking part
- Escalation phase: melanoma, brain tumors, glioblastoma, sarcoma or pancreatic ductal adenocarcinoma
- Active untreated brain metastases
- Pregnancy or breast-feeding
- HIV, hepatitis B, hepatitis C or active tuberculosis
- Allogenic tissue or solid organ transplant
Read by machine on 12 November 2026.
Where in Belgium
- Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi, BelgiumContact: Schroeder, Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sairopa B.V.
- Trial code
- NCT05856981
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
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).
Inclusion: Male or female aged ≥18 years; Signed and dated informed consent form; Measurable disease according to RECIST (Safety Expansion only); ECOG Performance status of 0 or 1; Adequate organ and marrow function; Escalation Phase: Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists; Expansion Phase: histologically and/or cytologically confirmed diagnosis of 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, and that have measurable disease according to RECIST.
Exclusion: Expansion Phase:; > 3 lines of prior systemic treatments; MSS colorectal cancer (CRC): liver metastasis present; Prior treatment with or receipt of:; biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805; chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C; anti-SIRPα or anti-CD47-directed therapy; systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805; other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805; vaccine containing live virus within 28 prior to the first dose of ADU-1805; Current Grade >2 toxicity related to prior anti-cancer therapy; Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients; Major surgery within defined period; Allogenic tissue/solid organ transplant; Active infection requiring systemic therapy; Impaired cardiac function or clinically significant cardiac disease; History of drug-induced severe immune-related adverse reaction; Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis; Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study; Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC); Pregnancy or breast-feeding; Active untreated brain metastases.