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

Last updated: May 13, 2025
Sponsor: Sairopa B.V.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Pembrolizumab

ADU-1805

Clinical Study ID

NCT05856981
SRP-22C102
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged ≥18 years

  • Signed and dated informed consent form

  • Histologically and/or cytologically confirmed diagnosis of metastatic orunresectable solid tumors that are refractory to standard therapy or for which nostandard therapy exists

  • Measurable disease according to RECIST (Safety Expansion only)

  • ECOG Performance status of 0 or 1

  • Adequate organ and marrow function

Exclusion

Exclusion Criteria:

  • Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma andpancreatic ductal adenocarcinoma (PDAC)

  • 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 radiationtherapy within 21 days prior to the first dose of ADU-1805 and within 42 daysfor nitrosoureas and mitomycin C.

  • anti-SIRPα or anti-CD47-directed therapy

  • systemic chronic steroid therapy or immunosuppressive therapy within 14 daysprior to the first dose of ADU-1805

  • other investigational new drug or investigational device within 28 days priorto 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 significancethat it would interfere with the patient's safety or ability to participate in thestudy

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
April 03, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The study will start with the ADU-1805 monotherapy dose escalation arm following an i3+3 design until the RP2D is defined. The ADU-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the ADU-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the RP2D for the combination is defined.

Connect with a study center

  • Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame

    Charleroi,
    Belgium

    Active - Recruiting

  • National Institute of Oncology

    Chișinău,
    Moldova, Republic of

    Active - Recruiting

  • Hosp 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gergorio Maranon

    Madrid,
    Spain

    Active - Recruiting

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University Medical Campus

    St. Louis, Missouri 63110
    United States

    Active - Recruiting

  • Carolina BioOncology Institute - Cancer Research Clinic

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Gabrail Cancer & Research Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    FairFax, Virginia 22205
    United States

    Active - Recruiting

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