Evaluating a new treatment for advanced solid tumors
An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
This study is testing a new treatment called ADU-1805 for people with advanced solid tumors to see how safe it is and how well it works on its own and with another drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sairopa B.V. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, pembrolizumab |
| Locations | 7 sites (Detroit, Michigan and 6 other locations) |
| Trial ID | NCT05856981 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label, multicenter, multi-arm dose-escalation study aims to assess the safety, pharmacokinetics, and pharmacodynamics of ADU-1805, an anti-SIRPα monoclonal antibody. The study will begin with a dose escalation of ADU-1805 as a monotherapy, followed by a combination with pembrolizumab after determining the maximum target engagement. The design follows an i3+3 approach to establish the recommended phase 2 dose (RP2D) for both treatment arms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic or unresectable solid tumors that have not responded to standard treatments.
Not a fit: Patients with specific cancers such as melanoma, brain tumors, glioblastoma, sarcoma, or pancreatic ductal adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are refractory to standard therapies.
How similar studies have performed: Other studies involving immunotherapy approaches have shown promise, but this specific combination is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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: * 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: * 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
Where this trial is running
Detroit, Michigan and 6 other locations
- Henry Ford Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Washington University Medical Campus — St Louis, Missouri, United States (Recruiting)
- Gabrail Cancer & Research Center — Canton, Ohio, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame — Charleroi, Belgium (Recruiting)
- Hosp 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital General Universitario Gergorio Maranon — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Sairopa Clinical Team
- Email: clinical@sairopa.com
- Phone: 0031 85 90 26 939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.