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RecruitingPhase 1NCT05856981
Official study title

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedADU-1805 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 17, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Sairopa B.V.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Sairopa B.V.
Interventions being studied
Drug: ADU-1805; Drug: Pembrolizumab
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Resistant or refractory→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Henry Ford Cancer InstituteDetroit, Michigan
  • Washington University Medical CampusSt Louis, Missouri
  • Gabrail Cancer & Research CenterCanton, Ohio
  • Virginia Cancer SpecialistsFairfax, Virginia
  • Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi
  • Hosp 12 de OctubreMadrid
  • Hospital General Universitario Gergorio MaranonMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 17, 2025. Always confirm current availability with the study team.

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