> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-study-evaluating-the-safety-and-pk-of-adu-1805-in-2980f3fc-924d-41b0-8425-734c857017e9 > Record changed: 2026-11-04 # Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors NCT05856981 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Lead sponsor Sairopa B.V. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Start date 2023-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Short title** Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Official title** An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Dates **Completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **First posted** 2023-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Registry last updated** 2026-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Start date** 2023-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Size and sites **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Planned participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Lead sponsor** Sairopa B.V. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Identifiers **Registry ID** NCT05856981 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **ClinicalTrials.gov ID** NCT05856981 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Outcomes ### Primary outcomes 1. Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters Timeframe: First 21 days of treatment Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0 2. Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion. Timeframe: Through study completion, up to 2,5 years Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 ### Secondary outcomes 1. Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters Timeframe: Through study completion, up to 2,5 years Serum concentration-time profiles and PK parameters (including Cmax, AUC) 2. Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab Timeframe: Through study completion, up to 2,5 years Incidence of anti-ADU-antibodies 3. Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion Timeframe: Through study completion, up to 2,5 years Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Sites - Henry Ford Cancer InstituteDetroit, United StatesRecruiting - Washington University Medical CampusSt Louis, United StatesRecruiting - Atrium Health Carolinas Medical CenterCharlotte, United StatesRecruiting - Gabrail Cancer & Research CenterCanton, United StatesRecruiting - The Ohio State University Comprehensive Cancer CenterColumbus, United StatesRecruiting - University of Texas Southwestern Medical CenterDallas, United StatesRecruiting - Start Center for Cancer Research - Mountain RegionWest Valley City, United StatesRecruiting - Virginia Cancer SpecialistsFairfax, United StatesRecruiting - Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi, BelgiumRecruiting - Hosp 12 de OctubreMadrid, SpainRecruiting - Hospital General Universitario Gergorio MaranonMadrid, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05856981) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Sairopa B.V.](https://trialight.com/data/company/sairopa-b-v-01de812a-d407-43ce-a96c-1eb89e6585e0.md) ### Conditions (7) - [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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