Solid Tumor, AdultPhase 1NCT05856981
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
A Phase 1 study testing ADU-1805 and Pembrolizumab in people with Solid Tumor, Adult and Metastatic Solid Tumor, run by Sairopa B.V. at 7 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer
- What is being tested?
- ADU-1805 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 3 Apr 2023to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 22Show fewer
- 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
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Gabrail Cancer & Research Center
Canton, Ohio, 44718
Gabrail, Dr.
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Weise, Dr.
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22205
Spira, Dr.
- Recruiting
Washington University Medical Campus
St Louis, Missouri, 63110
Khushman, Dr.
Spain2 sites, 2 recruiting
- Recruiting
Hosp 12 de Octubre
Madrid
de Velasco, Dr.
- Recruiting
Hospital General Universitario Gergorio Maranon
Madrid
Calvo, Dr.
Belgium1 site, 1 recruiting
- Recruiting
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi
Schroeder, Dr.
About this study
Official title: 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).
Read the 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.
- Conditions
- Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer, CRC, Colorectal Cancer, RCC, Clear Cell Adenocarcinoma, NSCLC (Advanced Non-small Cell Lung Cancer)
- Being tested
- ADU-1805, Pembrolizumab
- Keywords
- Immunotherapy
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADU-1805Drug
anti-SIRPα monoclonal antibody
PembrolizumabDrug
Also called Keytruda
Keytruda
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy dose escalation, IV, Q3W, multiple dose levels | Experimental | ADU-1805 monotherapy dose escalation Receives: Drug: ADU-1805 |
| Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose | Experimental | ADU-1805 plus pembrolizumab dose escalation Receives: Drug: ADU-1805; Drug: Pembrolizumab |
| Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose | Experimental | ADU-1805 plus pembrolizumab dose expansion Receives: Drug: ADU-1805; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0
Measured: First 21 days of treatment
Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.
Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Through study completion, up to 2,5 years
Secondary outcomes (3)
Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters
Serum concentration-time profiles and PK parameters (including Cmax, AUC)
Measured: Through study completion, up to 2,5 years
Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Incidence of anti-ADU-antibodies
Measured: Through study completion, up to 2,5 years
Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion
Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters.
Measured: Through study completion, up to 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start3 Apr 2023
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sairopa B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856981
- Sponsor's protocol ID
- SRP-22C102
- Status last verified
- May 2025
- First submitted
- 4 Jan 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05856981
- Acronym / sponsor ID
- SRP-22C102
- Conditions
- Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer, CRC, Colorectal Cancer, RCC, Clear Cell Adenocarcinoma, NSCLC (Advanced Non-small Cell Lung Cancer)
- Keywords
- Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sairopa B.V.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy dose escalation, IV, Q3W, multiple dose levels | Experimental | Drug: ADU-1805ADU-1805 monotherapy dose escalation |
| Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose | Experimental | Drug: ADU-1805, Drug: PembrolizumabADU-1805 plus pembrolizumab dose escalation |
| Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose | Experimental | Drug: ADU-1805, Drug: PembrolizumabADU-1805 plus pembrolizumab dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
- Expansion Phase:
- Pregnancy or breast-feeding
- Prior treatment with or receipt of:
- Active untreated brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADU-1805anti-SIRPα monoclonal antibody | Drug | Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose, Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose, Monotherapy dose escalation, IV, Q3W, multiple dose levels |
| PembrolizumabAlso: KeytrudaKeytruda | Drug | Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose, Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose |
Primary outcome
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
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
3 secondary outcomes
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
Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
Not yet recruitingPhase 1
An Investigational Study of BON-106 in Adults With Advanced or Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 2
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADU-1805 and Pembrolizumab in people with Solid Tumor, Adult and Metastatic Solid Tumor, run by Sairopa B.V. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sairopa Clinical Team (0031 85 90 26 939, clinical@sairopa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.