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Phase 1 Study of ADU-1805 for Advanced Solid Tumors

This study is testing a new drug called ADU-1805, alone and with Pembrolizumab (Keytruda), for people with advanced solid tumors that haven't responded to standard treatments. ADU-1805 is a type of monoclonal antibody, which is a lab-made protein that can block specific targets in the body. The main goals are to find out if ADU-1805 is safe, how much can be given, and to see if it has any effect on the cancer. You might be able to join if you are at least 18 years old, have certain types of advanced solid tumors, and meet other health requirements. The study plans to enroll about 130 participants.

Study design
This is a first-in-human, open-label study, meaning both you and the study team will know which treatment you are receiving. It includes a dose escalation phase to find the right dose, followed by a dose expansion phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate clinical response through study completion, which can be up to 2.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05856981

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Sairopa B.V.
~130 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:ADU-1805Pembrolizumab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Measured over First 21 days of treatment
+1 more outcome measured

Conditions

Solid Tumor, Adult
Metastatic Solid Tumor
Refractory Cancer
CRC, Colorectal Cancer
RCC, Clear Cell Adenocarcinoma
NSCLC (Advanced Non-small Cell Lung Cancer)
Endometrial Cancer

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Colorectal CarcinomaEndometrial CarcinomaLung Non-Small Cell CarcinomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

7 sites across 6 states
Spain2
Michigan1
Missouri1
Ohio1
Virginia1
Belgium1

Who to contact

Sairopa Clinical Team
[email protected]
0031 85 90 26 939
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parametersFirst 21 days of treatment

    Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0

  • Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.Through study completion, up to 2,5 years

    Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1