Recruiting
Phase 1

ADU-1805

Sponsor:

Sairopa B.V.

Code:

NCT05856981

Conditions

Solid Tumor, Adult

Metastatic Solid Tumor

Refractory Cancer

CRC, Colorectal Cancer

RCC, Clear Cell Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADU-1805

Pembrolizumab

Study Details

Brief 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).

Conditions

Solid Tumor, Adult

Metastatic Solid Tumor

Refractory Cancer

CRC, Colorectal Cancer

RCC, Clear Cell Adenocarcinoma

Study ID

NCT05856981

Start date

Apr 3, 2023

Status verified date

May, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy dose escalation, IV, Q3W, multiple dose levels

ADU-1805 monotherapy dose escalation

experimental: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

ADU-1805 plus pembrolizumab dose escalation

experimental: Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

ADU-1805 plus pembrolizumab dose expansion

Interventions

ADU-1805

anti-SIRPα monoclonal antibody

Pembrolizumab

Keytruda

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Sairopa Clinical Team

0031 85 90 26 939clinical@sairopa.com

Locations

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

Washington University Medical Campus

Recruiting

St Louis, Missouri, United States, 63110

Gabrail Cancer & Research Center

Recruiting

Canton, Ohio, United States, 44718

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22205

More Information

Sponsor

Sairopa B.V.

Last update posted

Dec 17, 2025

Last verified

May, 2025

Keywords

  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sairopa B.V. on 2025-12-17.