Actively Recruiting
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Led by Sairopa B.V. · Updated on 2025-12-17
130
Participants Needed
7
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 3518 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
- For Escalation Phase: Confirmed metastatic or unresectable solid tumors refractory to standard therapy or without standard therapy
- For Expansion Phase: Confirmed advanced PD-(L)1-na�efve MSS colorectal cancer, PD-1 relapsed/refractory advanced MSS endometrial cancer, renal cell carcinoma, or non-small cell lung cancer with measurable disease according to RECIST
You will not qualify if you...
- For Escalation Phase: Patients with melanoma, brain tumors, glioblastoma, sarcoma, or pancreatic ductal adenocarcinoma
- For Expansion Phase: More than 3 prior systemic treatment lines
- For Expansion Phase: Presence of liver metastasis in MSS colorectal cancer
- Pregnancy or breastfeeding
- Recent treatment with biological agents, chemotherapy, targeted therapy, hormonal therapy, radiation, anti-SIRP�b1 or anti-CD47 therapies within specified timeframes
- Systemic chronic steroid or immunosuppressive therapy within 14 days prior to first dose
- Participation in other investigational drug or device studies within 28 days
- Vaccination with live virus within 28 days prior to first dose
- Active untreated brain metastases
- Active infection requiring systemic therapy
- Impaired cardiac function or significant cardiac disease
- Current Grade >2 toxicity related to prior anti-cancer therapy
- History of severe immune-related adverse reaction to drugs
- Severe hypersensitivity to monoclonal antibodies or ADU-1805 components
- Recent major surgery within defined period
- Diagnosis or positive test for HIV, hepatitis B or C, or active tuberculosis
- Allogenic tissue or solid organ transplant
- Any life-threatening or clinically significant intercurrent illness interfering with safety or study participation
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Washington University Medical Campus
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Gabrail Cancer & Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
4
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22205
Actively Recruiting
5
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi, Belgium
Actively Recruiting
6
Hosp 12 de Octubre
Madrid, Spain
Actively Recruiting
7
Hospital General Universitario Gergorio Maranon
Madrid, Spain
Actively Recruiting
Research Team
S
Sairopa Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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