OncoMatch/Clinical Trials/NCT05856981
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Is NCT05856981 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including ADU-1805 and Pembrolizumab for solid tumor, adult.
Treatment: ADU-1805 · Pembrolizumab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Colorectal Cancer
Renal Cell Carcinoma
Non-Small Cell Lung Carcinoma
Endometrial Cancer
Biomarker criteria
Required: PD-L1 (CD274) PD-(L)1-naïve
advanced PD-(L)1-naïve MSS colorectal cancer (CRC)
Required: PD-L1 (CD274) PD-1 relapsed/refractory
PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients
Required: MSH2 microsatellite stable
MSS colorectal cancer (CRC), MSS endometrial cancer (EC)
Disease stage
Required: Stage IV
Metastatic disease required
measurable disease according to RECIST (Safety Expansion only); metastatic or unresectable solid tumors; advanced ... CRC, EC, RCC, NSCLC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
refractory to standard therapy or for which no standard therapy exists
Cannot have received: biological agent (monoclonal antibody, immunotherapy)
biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805
Cannot have received: chemotherapy
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
Cannot have received: targeted small molecule therapy
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
Cannot have received: hormonal therapy
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
Cannot have received: radiation therapy
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
Cannot have received: nitrosourea
within 42 days for nitrosoureas and mitomycin C
Cannot have received: mitomycin C (mitomycin C)
within 42 days for nitrosoureas and mitomycin C
Cannot have received: anti-SIRPα therapy
anti-SIRPα or anti-CD47-directed therapy
Cannot have received: anti-CD47 therapy
anti-SIRPα or anti-CD47-directed therapy
Cannot have received: systemic chronic steroid therapy
systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805
Cannot have received: immunosuppressive therapy
systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805
Cannot have received: investigational new drug
other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805
Cannot have received: investigational device
other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805
Cannot have received: live virus vaccine
vaccine containing live virus within 28 prior to the first dose of ADU-1805
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Impaired cardiac function or clinically significant cardiac disease excluded
Adequate organ and marrow function; Impaired cardiac function or clinically significant cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Henry Ford Cancer Institute · Detroit, Michigan
- Washington University Medical Campus · St Louis, Missouri
- Gabrail Cancer & Research Center · Canton, Ohio
- Virginia Cancer Specialists · Fairfax, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05856981 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior biological agent, chemotherapy, targeted small molecule therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 PD-(L)1-naïve is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 PD-1 relapsed/refractory is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 microsatellite stable is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify