NCT05856981
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Recruiting · Phase 1 · Sairopa B.V. · registry updated 2025-12-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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).
Inclusion
- 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
Exclusion
- 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: