Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to measure the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as this drug alone and in combination with pembrolizumab (anti-PD-1 antibody).
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ADU-1805, or Pembrolizumab. The registry lists allocation as randomized. This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to measure the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as this drug alone and in combination with pembrolizumab (anti-PD-1 antibody).
They plan to enroll about 130 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
Primary outcome (registry wording): Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Who it is for (from inclusion criteria)
Ages 18 Years to any
Male or female aged ≥18 years
Measurable disease according to RECIST (Safety Expansion only)
how well you can do daily activities (ECOG score) 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
Who the registry excludes
Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
\> 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
Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05856981?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05856981?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.