Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
NCT ID: NCT05856981
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2023-04-03
2027-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy dose escalation, IV, Q3W, multiple dose levels
ADU-1805 monotherapy dose escalation
ADU-1805
anti-SIRPα monoclonal antibody
Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
ADU-1805 plus pembrolizumab dose escalation
ADU-1805
anti-SIRPα monoclonal antibody
Pembrolizumab
Keytruda
Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
ADU-1805 plus pembrolizumab dose expansion
ADU-1805
anti-SIRPα monoclonal antibody
Pembrolizumab
Keytruda
Interventions
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ADU-1805
anti-SIRPα monoclonal antibody
Pembrolizumab
Keytruda
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sairopa B.V.
INDUSTRY
Responsible Party
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Locations
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Henry Ford Cancer Institute
Detroit, Michigan, United States
Washington University Medical Campus
St Louis, Missouri, United States
Gabrail Cancer & Research Center
Canton, Ohio, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi, , Belgium
Hosp 12 de Octubre
Madrid, , Spain
Hospital General Universitario Gergorio Maranon
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Weise, Dr.
Role: primary
Khushman, Dr.
Role: primary
Gabrail, Dr.
Role: primary
Spira, Dr.
Role: primary
Schroeder, Dr.
Role: primary
de Velasco, Dr.
Role: primary
Calvo, Dr.
Role: primary
Other Identifiers
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SRP-22C102
Identifier Type: -
Identifier Source: org_study_id