New antibody combo takes on Hard-to-Treat cancers
NCT ID NCT05856981
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests an experimental drug called ADU-1805, alone or combined with the immunotherapy Keytruda, in adults with advanced solid tumors that have stopped responding to standard treatments. The main goals are to check safety and find the right dose. About 130 participants will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADU-1805 (an experimental antibody) and pembrolizumab (Keytruda)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial with a small number of participants, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gabrail Cancer & Research Center
RECRUITINGCanton, Ohio, 44718, United States
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Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
RECRUITINGCharleroi, Belgium
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Henry Ford Cancer Institute
RECRUITINGDetroit, Michigan, 48202, United States
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Hosp 12 de Octubre
RECRUITINGMadrid, Spain
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Hospital General Universitario Gergorio Maranon
RECRUITINGMadrid, Spain
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Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22205, United States
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Washington University Medical Campus
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink tumors that resist standard care?
- Can protein patterns in stored tumors point to new treatment targets?
- Can a new drug combo shrink advanced colorectal tumors?
- A new imaging agent aims to make solid tumors visible on PET scans
- Can a radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?