NCT05856981 · Sairopa B.V.
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
What this study is about
This first-in-human, where both patients and doctors know the treatment given, conducted at multiple hospitals, multi-treatment group$1 gradually increasing doses study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as treatment given alone and in combination with pembrolizumab (anti-PD-1 antibody).
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
- Expansion Phase:
- \> 3 lines of prior systemic treatments
- MSS colorectal cancer (CRC): liver metastasis present
- Pregnancy or breast-feeding
- 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
- Active untreated brain metastases
- Active infection requiring systemic therapy
- Impaired cardiac function or clinically significant cardiac disease
- Current Grade \>2 toxicity related to prior anti-cancer therapy
- History of drug-induced severe immune-related adverse reaction
- Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
- Major surgery within defined period
- Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
- Allogenic tissue/solid organ transplant
- 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
Where
- Detroit, Michigan
- St Louis, Missouri
- Canton, Ohio
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations