Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing ADU-1805, an antibody that blocks SIRPα, a signal that can restrain macrophages (immune cells that engulf abnormal cells), either alone or with pembrolizumab, which helps T cells attack cancer. The idea is that combining these immune mechanisms might improve recognition and killing of tumour cells, but this trial is first establishing how the treatment behaves in the body and what doses are safe.
The researchers hope that releasing two different immune brakes could eventually control cancer better than either approach alone. In this study, however, improvement mainly means finding a tolerable dose and characterising side effects and drug activity; it is not designed to show whether people live longer or stay progression-free.
Worth knowing: This is a small, non-randomised, open-label phase 1 study, so it has no comparison group and is primarily testing safety rather than treatment benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05856981 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 130 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Sairopa B.V. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug ADU-1805
- Drug Pembrolizumab
What it is measuring
Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 11 sites. Listed in: Belgium, Spain, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05856981, registered by Sairopa B.V. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.