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
Where in Belgium
- Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi, BelgiumTaking 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?
Trial 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.