Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer, CRC, Colorectal Cancer, RCC, Clear Cell Adenocarcinoma, NSCLC (Advanced Non-small Cell Lung Cancer), Endometrial Cancer

In brief

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).

Key facts

Study ID

NCT05856981

Run by

Sairopa B.V.

People needed

130

Starts

2023-04-03

Expected to finish

2027-07-01

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University Medical Campus — St Louis, Missouri, United States (enrolling)
• Gabrail Cancer & Research Center — Canton, Ohio, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame — Charleroi, Belgium (enrolling)
• Hosp 12 de Octubre — Madrid, Spain (enrolling)
• Hospital General Universitario Gergorio Maranon — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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