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

December 9, 2025 updated by: Sairopa B.V.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate the safety, PK, PD and preliminary clinical activity of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody). The study is divided into a dose escalation phase and a dose expansion phase.

The dose expansion phase investigates ADU-1805 plus pembrolizumab at the respective recommended phase 2 dose (RP2D) in four advanced solid tumors: 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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Charleroi, Belgium
        • Recruiting
        • Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
        • Contact:
          • Schroeder, Dr.
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hosp 12 de Octubre
        • Contact:
          • de Velasco, Dr.
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gergorio Maranon
        • Contact:
          • Calvo, Dr.
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer Institute
        • Contact:
          • Weise, Dr.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Medical Campus
        • Contact:
          • Khushman, Dr.
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer & Research Center
        • Contact:
          • Gabrail, Dr.
    • Virginia
      • Fairfax, Virginia, United States, 22205
        • Recruiting
        • Virginia Cancer Specialists
        • Contact:
          • Spira, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy dose escalation, IV, Q3W, multiple dose levels
ADU-1805 monotherapy dose escalation
Drug: ADU-1805
anti-SIRPα monoclonal antibody
Experimental: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
ADU-1805 plus pembrolizumab dose escalation
Drug: Pembrolizumab
Keytruda
Other Names:
  • Keytruda
Drug: ADU-1805
anti-SIRPα monoclonal antibody
Experimental: Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
ADU-1805 plus pembrolizumab dose expansion
Drug: Pembrolizumab
Keytruda
Other Names:
  • Keytruda
Drug: ADU-1805
anti-SIRPα monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Time Frame: First 21 days of treatment
Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0
First 21 days of treatment
Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.
Time Frame: Through study completion, up to 2,5 years
Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Through study completion, up to 2,5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters
Time Frame: Through study completion, up to 2,5 years
Serum concentration-time profiles and PK parameters (including Cmax, AUC)
Through study completion, up to 2,5 years
Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Time Frame: Through study completion, up to 2,5 years
Incidence of anti-ADU-antibodies
Through study completion, up to 2,5 years
Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion
Time Frame: Through study completion, up to 2,5 years
Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters.
Through study completion, up to 2,5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escalation and Expansion Phase: Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Time Frame: Through end of treatment, up to 2 years
Investigate the mechanism of action and pharmacodynamics (PD) of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab using tumor tissue and blood biomarkers (e.g. immune monitoring)
Through end of treatment, up to 2 years
Escalation and Expansion Phase: Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Time Frame: Through study completion, up to 2,5 years
Overall and duration of response per (i)RECIST, PFS, (duration) of disease control, OS
Through study completion, up to 2,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sairopa B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRP-22C102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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